K251089 is an FDA 510(k) clearance for the EXEL Disposable Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Exelint International, Co. (Redondo Beach, US). The FDA issued a Cleared decision on December 12, 2025, 246 days after receiving the submission on April 10, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K251089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 246 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 |