Merit Syringe
by Merit Medical Systems, Inc. 5 variants
510(k) K182279
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182279 | Date6 Nov 2018 | StatusActive |
Official records
- FDA 510(k) database K182279
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- Withdrawn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, 19 Sep 2026
The Merit Syringe is a medical device classified as a syringe (product code FMF), designed for the precise administration or withdrawal of fluids in clinical settings. Constructed for reliability, it is intended for general hospital use, adhering to standards for fluid handling in procedural and diagnostic applications.
Supplied as a single-use device, the Merit Syringe is intended for sterile use in controlled environments such as operating rooms, procedure rooms, or clinical examination settings. It is cleared by the FDA under 510(k) clearance (K182279) as substantially equivalent to predicate devices, with no third-party certification noted. Sizes and configurations are not specified in the provided data, but the device follows standard syringe design principles for compatibility with luer connectors.
From the manufacturer
Since 1987 Merit Medical has been manufacturing and selling a variety of coronary control syringes. With years of experience, Merit has designed and created quality control syringes with features that continue to meet ever changing clinical expectations.
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. Your Merit Representative will provide you with the corresponding catalog number.