K250192 is an FDA 510(k) clearance for the Verisafe Safety Retractable Insulin Syringes. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on December 10, 2025, 321 days after receiving the submission on January 23, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K250192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2025 |
| Decision Date | December 10, 2025 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |