K250853 is an FDA 510(k) clearance for the Merit Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 4, 2025, 228 days after receiving the submission on March 21, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K250853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2025 |
| Decision Date | November 04, 2025 |
| Days to Decision | 228 days |
| Submission Type | Special |
| 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 |