K231038 is an FDA 510(k) clearance for the Global Hypoperfusion Index (GHI) Algorithm. This device is classified as a Medium-term Adjunctive Predictive Cardiovascular Indicator (Class II - Special Controls, product code QNL).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 26, 2023, 105 days after receiving the submission on April 12, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2210. The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K231038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2023 |
| Decision Date | July 26, 2023 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QNL — Medium-term Adjunctive Predictive Cardiovascular Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2210 |
| Definition | The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |