FDA 510(k) Regulatory Intelligence Database
An independent FDA 510(k) intelligence platform for regulatory affairs professionals, medtech consultants and compliance teams. Search 174,000+ clearances, identify predicate devices for 510(k) submissions, benchmark FDA review timelines and research regulatory consulting firms - all from official FDA data.
FDA 510(k) Regulatory Intelligence Tools for Medical Device Compliance and Strategy Teams
510k Database structures FDA 510(k) clearance records into a structured, queryable dataset for regulatory affairs professionals, compliance teams, and medtech consultants. The platform enables analysis of real submission data from FDA accessdata.gov, including manufacturers, consultants, product codes, FDA panels, and clearance timelines.
Browse and compare FDA 510(k) consultants
Explore regulatory consulting firms ranked by real FDA 510(k) submission volume. Analyze which consultants manage submissions across device categories, review clearance activity, and identify specialization by FDA panel and regulatory pathway.
View ranked consultant databaseAnalyze FDA 510(k) AI imaging & SaMD predicate strategies
Explore how AI medical devices and Software as a Medical Device (SaMD) products navigate the FDA 510(k) pathway using QIH device codes. Compare predicate device selection, clearance timelines, and review patterns across AI imaging systems and automated diagnostic tools.
Explore AI 510(k) clearancesCompare FDA 510(k) submission timelines by manufacturer and device type
Analyze real FDA 510(k) clearance timelines across medical device manufacturers. Identify fast vs slow review cycles by product code, FDA panel, and submission year, based on structured FDA accessdata.gov submission records.
Search FDA 510(k) submission dataCompare FDA 510(k) review times by specialty panel
Analyze FDA 510(k) clearance durations across all medical device specialty panels. Compare average review times by panel, identify outliers, and determine whether a submission is fast or delayed based on historical FDA accessdata.gov records.
Explore FDA review time dataExplore FDA 510(k) product codes and device classification patterns
Analyze how medical devices are grouped within FDA 510(k) product codes and classification categories. Browse 339 device categories to understand regulatory requirements, competitive density, and submission patterns across the FDA classification system.
Browse FDA device classification databaseTrack FDA 510(k) submission activity by medical device manufacturer
Analyze clearance volume, category distribution, and submission patterns across 7,955+ medical device manufacturers. Compare global medtech companies and emerging startups using real FDA 510(k) accessdata.gov submission records.
Browse FDA manufacturer databaseMonthly FDA 510(k) Clearance Analysis
Each month, we analyze all FDA 510(k) clearances from the previous month, breaking down totals by medical specialty, average review time, and most active manufacturers. Reports are published on the 5th of each month directly from official FDA data. Browse all monthly reports.
FDA 510(k) Regulatory Intelligence - Beyond the Official FDA Records
Each device record is enriched with the regulatory consulting firm that managed the submission, linked clinical trial data from ClinicalTrials.gov, and submission flags including third-party review, combination product status and PCCP authorization - intelligence not available in the FDA's downloadable files.
Benchmark review timelines across 20 FDA panels - median 129 days for cleared devices versus 337 days for denied submissions - identify predicate devices, track manufacturer clearance velocity, and analyze AI and SaMD regulatory pathways across 174,000+ clearances.
Anesthesiology Medical Devices
8,948 devicesVentilators, anesthesia delivery systems and breathing circuits used in operating rooms and ICUs. Includes airway management devices, patient warming systems and perioperative monitoring equipment.
One of the more predictable FDA panels: average clearance of 139 days, with one of the lowest denial rates across all device categories. 9 submissions include linked clinical trial evidence.
Cardiovascular Medical Devices
18,004 devicesCatheters, stents, pacemakers and electrophysiology systems used in interventional cardiology and cardiac surgery. Includes hemodynamic monitoring, vascular grafts and heart failure management devices.
The panel with the highest number of linked clinical trials across all FDA categories - 38 submissions reference registered ClinicalTrials.gov studies, reflecting the clinical evidence demands of this high-stakes specialty. Average clearance: 124 days.
Chemistry Medical Devices
13,221 devicesIn vitro diagnostic analyzers and reagent systems used in clinical laboratories for blood chemistry, metabolite testing and point-of-care diagnostics.
The fastest-clearing major FDA panel, averaging just 88 days to decision - significantly below the cross-panel median. 15 submissions carry linked clinical trial evidence from ClinicalTrials.gov.
Dental Medical Devices
12,535 devicesImplant systems, intraoral scanners and CAD/CAM restorative platforms used across general dentistry and oral surgery. Includes AI-powered diagnostic tools, orthodontic devices and digital workflow systems.
The lowest denial rate of all 20 FDA review panels - fewer than 1 in 1,000 dental 510(k) submissions results in a Not Substantially Equivalent determination. Average review: 127 days.
Ear, Nose, Throat Medical Devices
3,791 devicesCochlear implants, ENT endoscopes and surgical navigation systems used in otolaryngology practices and ENT surgery. Includes hearing diagnostics, balloon sinuplasty and airway management tools.
Among the faster FDA panels for clearance decisions, averaging 88 days - on par with Chemistry. Low overall submission volume relative to surgical panels.
Gastroenterology & Urology Medical Devices
9,824 devicesEndoscopes, GI stents and urological devices used in gastroenterology suites, urology clinics and minimally invasive surgery. Includes colonoscopy systems, lithotripsy and bladder management devices.
One of the panels with the highest denial counts among mid-size categories - 47 Not Substantially Equivalent decisions on record. Average clearance: 129 days. 12 submissions with linked clinical trials.
General & Plastic Surgery Medical Devices
18,146 devicesElectrosurgical units, surgical lasers and laparoscopic instrument systems used across general surgery, plastic surgery and wound care. Includes energy-based tissue management, liposuction and minimally invasive closure devices.
One of the three largest FDA panels with over 18,100 clearances. 24 submissions carry linked clinical trial evidence - the second highest among all panels. Average clearance: 114 days.
General Hospital Medical Devices
17,734 devicesInfusion pumps, patient monitoring systems and vascular access devices used across all hospital departments. The broadest device category, covering ICU equipment, surgical supplies and general clinical infrastructure.
One of the three highest-volume FDA panels with over 17,700 clearances. Average review: 128 days, with a denial rate under 0.15%.
Hematology Medical Devices
3,291 devicesHematology analyzers, cell counters and coagulation systems used in hospital labs and transfusion medicine. Critical instruments for complete blood count, hemostasis testing and blood banking workflows.
A stable regulatory pathway with a very low denial rate and average clearance of 112 days. 2 submissions carry linked clinical trial data.
Immunology Medical Devices
3,781 devicesImmunoassay platforms and autoimmune test systems used in clinical immunology labs and allergy clinics. Includes cytokine assays, protein quantification and transplant compatibility testing.
Average clearance of 104 days and a low denial rate. A relatively straightforward predicate-based pathway with no linked clinical trials currently recorded in 510(k) submissions.
Medical Genetics Medical Devices
19 devicesMolecular diagnostic systems and genetic analysis platforms used in clinical genetics labs and precision medicine programs. Includes chromosomal analysis tools and inherited disease screening devices.
The most challenging FDA regulatory pathway by far: with only 19 total submissions on record, 8 have been denied - a 42% denial rate, the highest of any panel. Average review time across all outcomes exceeds 399 days, signalling exceptional regulatory complexity in this emerging category.
Microbiology Medical Devices
7,038 devicesRapid diagnostic test kits, culture systems and molecular identification platforms used in hospital microbiology labs and infection control. Key tools for sepsis workup, antimicrobial stewardship and outbreak surveillance.
The panel with the highest denial rate among all major FDA categories - 62 Not Substantially Equivalent decisions on record. Predicate selection and submission strategy are particularly critical here. Average clearance: 100 days.
Neurology Medical Devices
6,214 devicesNeurostimulators, EEG systems and AI-powered surgical navigation used in neurology departments and neurosurgery. Includes deep brain stimulation, epilepsy monitoring and robotic-assisted cranial procedures.
The panel with the highest concentration of denials for AI and SaMD submissions - 54 Not Substantially Equivalent decisions on record. Average clearance of 146 days and 19 submissions with linked clinical trial evidence from ClinicalTrials.gov.
Obstetrics & Gynecology Medical Devices
4,469 devicesFetal monitoring systems, endometrial ablation devices and minimally invasive surgical tools used in obstetrics, gynecology and reproductive medicine. Includes diagnostic ultrasound and IUD delivery systems.
The slowest-clearing panel for approved devices across all 20 FDA categories, averaging 160 days to decision - a key timeline benchmark for manufacturers planning submissions in this specialty. 6 submissions carry linked clinical trial data.
Ophthalmic Medical Devices
5,094 devicesIntraocular lenses, ophthalmic lasers and retinal imaging systems used in ophthalmology clinics and eye surgery centers. Covers cataract surgery platforms, glaucoma management and AI-based retinal diagnostics.
The second highest clinical trial density of all panels - 25 submissions carry linked ClinicalTrials.gov evidence, reflecting the clinical data requirements of implantable and laser devices. Average clearance: 108 days.
Orthopedic Medical Devices
17,766 devicesJoint replacement systems, spinal implants and robotic surgical navigation used in orthopedic surgery and sports medicine. The largest FDA device category by submission volume, covering hip, knee, spine and extremity reconstruction.
Despite its scale, it maintains one of the lowest denial rates across all panels - under 0.1% of 17,700+ submissions. Average clearance: 122 days.
Pathology Medical Devices
1,099 devicesAutomated histology systems, digital pathology platforms and tissue staining instruments used in anatomical pathology labs and oncology workflows. Includes slide scanners and AI-assisted tumor grading tools.
A small but demanding panel: the fastest average clearance when approved at just 74 days, but with a denial rate exceeding 2% - the highest of any panel except Medical Genetics. Thorough predicate selection is essential.
Physical Medicine Medical Devices
5,431 devicesElectrotherapy systems, therapeutic ultrasound and rehabilitation equipment used in physical therapy clinics and sports medicine. Includes neuromuscular electrical stimulation, traction and diagnostic ultrasound for musculoskeletal assessment.
A reliable clearance pathway with a very low denial rate and average review of 115 days. 3 submissions carry linked clinical trial evidence.
Radiology Medical Devices
15,452 devicesCT, MRI, X-ray systems and AI-powered image analysis software used in hospital radiology departments and teleradiology platforms. The fastest-growing FDA panel, driven by AI imaging clearances under product code QIH.
Despite rapid growth in AI submissions, it maintains a low denial rate and an average clearance of 106 days - making it one of the more efficient panels for innovative device pathways.
Toxicology Medical Devices
3,026 devicesImmunoassay drug screening systems and therapeutic drug monitoring platforms used in emergency medicine, addiction treatment and forensic labs. Covers point-of-care and laboratory-based substance detection assays.
One of the fastest-clearing panels in the FDA portfolio, averaging just 86 days to clearance decision - among the lowest of all 20 review panels - with a low denial rate and well-established predicate landscape.
FDA 510(k) Medical Device Intelligence by Technology Category
Explore FDA 510(k) cleared medical devices organized by clinical application, technology type, and regulatory classification based on structured FDA accessdata.gov clearance records.
Device classification and category mapping is derived from FDA 510(k) clearance records and regulatory submission data, not curated listings.
FDA-cleared AI imaging tools for diagnostic radiology workflows
Bone fixation, spinal fusion and joint replacement devices
Stents, catheters and cardiac monitoring systems
Brain stimulation, neural monitoring and neurodiagnostic systems
Infusion pumps, patient monitoring and clinical support equipment
Intraoral scanners, AI diagnostics and implant platforms
Recently Cleared FDA 510(k) Medical Devices - Clearance Activity
Track newly cleared FDA 510(k) medical devices across all specialties, with monthly updates reflecting regulatory clearance activity.
Updates reflect FDA 510(k) clearance events derived from official submission records, not curated industry reports.
FDA 510(k) Medical Device Manufacturers by Submission Volume
Companies ranked by FDA 510(k) submission activity across the database, based on structured regulatory records of medical device clearances.
Built for FDA 510(k) regulatory and medtech decision-makers
510k Database is used across the medical device industry for regulatory intelligence, competitive benchmarking, and FDA 510(k) clearance analysis.
This platform is based on structured FDA 510(k) submission records and derived regulatory signals, enabling analysis of real clearance activity across manufacturers, devices, and review pathways.
Regulatory Affairs Teams - FDA 510(k) Research
Find predicate devices, benchmark FDA 510(k) review timelines, and track competitor submission activity across device categories and product codes.
MedTech Startups - 510(k) Pathway Strategy
Map FDA 510(k) predicate strategies used by cleared AI and SaMD companies. Understand likely clearance pathways before initiating your submission strategy.
Healthcare Investors - MedTech Regulatory Signals
Use FDA 510(k) clearance velocity and regulatory patterns as signals for market entry risk, competitive intensity, and medtech pipeline activity.
Regulatory Consultants - FDA 510(k) Benchmarking
Benchmark FDA 510(k) clearance timelines, identify regulatory pathway trends, and prepare market context for client submissions and strategic planning.
What is 510k Database?
510k Database is an independent FDA 510(k) regulatory intelligence platform that structures premarket notification data into searchable analytical insights. It is not affiliated with the FDA.
- 174,883 FDA 510(k) devices mapped into regulatory intelligence clusters across product codes, device categories, and 20 FDA review panels.
- Data sourced directly from the FDA 510(k) downloadable files and enriched with classification metadata.
- Updated automatically on the 5th of each month from official FDA records.
- Each device record includes regulatory pathway interpretation, FDA review time benchmarking, and manufacturer clearance profiles derived from submission-level data.
- Selected records include regulatory consulting firms associated with each submission - intelligence not available in FDA downloadable datasets.
- When a 510(k) references a registered clinical trial, the device record links to the full study data from ClinicalTrials.gov - including enrollment, outcomes and publication status.
How is this different from FDA.gov?
The FDA's accessdata search allows lookup of individual 510(k) submissions by K-number. 510k Database enables cross-submission analysis across 174,000+ records, including filtering by device category, review time, manufacturer, and regulatory pathway.
In addition, submissions are enriched with product codes, CFR classifications, and FDA panel assignments to enable comparative regulatory intelligence not available in the standard FDA interface.
Monthly clearance intelligence
Beyond the searchable database, we publish a monthly analysis of all FDA 510(k) clearances from the previous month. Each report covers total clearances by specialty, average FDA review time, and the most active manufacturers. These reports are used by regulatory teams to monitor market activity, track competitive entry into device categories, and analyze how FDA review times evolve across specialties over time.
What is a 510(k) clearance?
A 510(k) is a premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. Required for most Class I and Class II devices sold in the U.S.
Who uses this 510(k) database?
Regulatory affairs professionals, medical device manufacturers, healthcare procurement teams and researchers use this database to verify device clearances, find predicate devices and track competitor submissions.
How often is the data updated?
The FDA publishes updated 510(k) records on the 5th of each month. This database syncs automatically within 24 hours of each FDA release.
What do "cleared" and "not cleared" mean?
Cleared (SESE) means the FDA determined the device is substantially equivalent and may be marketed in the U.S. Not cleared (DENG) means the FDA found the device is not substantially equivalent to any predicate.
How do I search the FDA 510(k) database?
Use the search bar at the top of this page. You can search by device name, manufacturer name, or K-number (e.g. K243854). You can also browse by medical specialty or filter by decision, year, or product code. Results link directly to the full device record and the official FDA submission.
Is 510(k) clearance the same as FDA approval?
No. 510(k) clearance means the FDA determined a device is substantially equivalent to a legally marketed predicate device. It is used for most Class I and Class II devices. FDA approval (PMA - Premarket Approval) is a separate, more rigorous process required for high-risk Class III devices, based on clinical trial evidence of safety and effectiveness. It is legally incorrect to describe a 510(k)-cleared device as "FDA approved."
Are FDA 510(k) submissions public?
Yes, partially. The FDA publishes the decision, device name, applicant, product code, and a summary of safety and effectiveness for each 510(k) within 30 days of the decision. Detailed technical and proprietary information is withheld. Full submissions can be requested via FOIA, though they are often heavily redacted. All records in this database are sourced from the FDA 510(k) public files, which are in the public domain.
What are the three types of 510(k)?
The FDA recognizes three types of 510(k) submission. A Traditional 510(k) is the standard path, requiring full substantial equivalence documentation. A Special 510(k) is a streamlined path for modifications to a manufacturer's own legally marketed device. An Abbreviated 510(k) relies on FDA-recognized standards or special controls to demonstrate substantial equivalence, simplifying the submission.
Does a 510(k) clearance expire?
No, a 510(k) clearance does not have an expiration date. However, if a manufacturer makes a significant change to a cleared device - in design, materials, intended use, or manufacturing - a new 510(k) submission may be required before marketing the modified device. The FDA provides guidance on when changes require a new submission.
What additional information do device records include?
Beyond the core FDA clearance data, individual device records are progressively enriched with information from official public sources. This includes the regulatory consultant who managed the 510(k) submission - a signal useful for competitive intelligence - as well as flags for third-party review, combination product status, and Predetermined Change Control Plan (PCCP) authorization, relevant for AI and software-based devices. When a 510(k) references a registered clinical trial, the device record links to the full study data from ClinicalTrials.gov, including design, enrollment, outcomes and publication status. Not all records have been enriched - coverage expands over time.
Is this an official FDA database?
No. 510k Database is an independent, search tool built on top of the FDA's publicly available 510(k) data files. It is not affiliated with or endorsed by the U.S. Food and Drug Administration. The official FDA 510(k) search tool is available at accessdata.fda.gov. This database uses the same underlying public data but offers enhanced search, manufacturer profiles, product code browsing, and monthly clearance analysis not available on the FDA's own interface. Learn more on the About page.
How do I find a predicate device for a 510(k) submission?
Search by device type, product code, or manufacturer to find cleared devices that could serve as predicates. Use the advanced search to filter by FDA review panel, decision year, or product code and narrow results to your device category. Each device record links directly to the full submission on accessdata.fda.gov where predicate device information is documented. You can also browse by product code category to find all cleared devices within a specific classification, or explore devices by medical specialty.
How long does FDA 510(k) clearance take?
FDA 510(k) review time varies by device category, submission quality, and review pathway. While the FDA target review timeline is 90 days, real-world clearance timelines are often longer. Based on historical FDA submission records analyzed in this database, median review durations vary significantly across specialty panels and device types.
What is a predicate device in a 510(k) submission?
A predicate device is a legally marketed medical device used to demonstrate substantial equivalence during an FDA 510(k) submission. Manufacturers compare their new device to one or more predicates to show similar intended use, technology, and safety characteristics.
Search the FDA 510(k) Database
Updated monthly from FDA records. Browse clearance reports by specialty, review time and manufacturer - or search any of the 174,000+ devices directly.
Search all 510(k) clearances