Merit Syringe
by Merit Medical Systems, Inc. 5 variants
510(k) K250853
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250853 | Date4 Nov 2025 | StatusActive |
Official records
- FDA 510(k) database K250853
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMF
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Merit Syringe is a disposable medical device used in interventional, diagnostic and therapeutic procedures. It features a clear polycarbonate barrel with optional colored plungers and customized medication printing. The syringe is available with fixed male or slip luers for various medical applications.
The Merit Syringe is supplied as a single-use device and is not MRI safe. It is manufactured by Merit Medical Systems, Inc. and has received FDA 510(k) clearance with the product code FMF. The device is stored at room temperature and is authorized for use in general hospital settings.
From the manufacturer
An introduction to Merit Medical Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy.
Medallion® Syringes have clear polycarbonate barrels, optional colored plungers, customized medication printing and fixed male or slip luers. Select one option from each category and identify your custom medication be printed on the barrel.