K253622 is an FDA 510(k) clearance for the Safety Pen Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Ningbo Medsun Medical Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on March 18, 2026, 120 days after receiving the submission on November 18, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K253622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2025 |
| Decision Date | March 18, 2026 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |