Merit Syringe
by Merit Medical Systems, Inc. 5 variants
510(k) K173601
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173601 | Date31 Jan 2018 | StatusActive |
Recalls
-
- Terminated Z-2742-2018
Supplier manufacturing defect with the syringe plunger tip.
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- Withdrawn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, 1 Oct 2026
The Merit Syringe is a medical syringe classified under the product code FMF, designed for fluid administration, aspiration, or medication delivery in clinical settings. It is intended for general hospital use and adheres to regulatory standards for single-use disposable devices. Constructed for precision and reliability, it supports routine procedural needs in diagnostic and therapeutic environments.
Supplied as a single-use, sterile device, the Merit Syringe is intended for use in controlled clinical environments such as hospitals and outpatient care facilities. It is regulated under FDA 510(k) clearance (K173601) as substantially equivalent to predicate devices, ensuring compliance with U.S. medical device regulations. Available in standard configurations, it requires proper storage to maintain sterility and integrity before use, with no noted MRI safety restrictions.
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.
The content on is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions.
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 to be printed on the barrel.
Other devices from Merit Medical Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Merit Syringe designed for in clinical settings?
The Merit Syringe is specifically designed for fluid administration, aspiration, or medication delivery in controlled clinical environments. Its general hospital classification (product code FMF) and regulatory compliance ensure it meets routine procedural needs in both diagnostic and therapeutic settings.
Is the Merit Syringe intended for single-use or reuse?
The Merit Syringe is explicitly intended for single-use only. This design choice aligns with regulatory standards for disposable medical devices, ensuring sterility and safety for each patient encounter without risk of cross-contamination.
How should the Merit Syringe be stored to maintain sterility?
The Merit Syringe must be stored in its original packaging under conditions that preserve sterility and integrity. Proper storage prevents contamination and ensures the device remains ready for immediate use in clinical procedures.
Does the Merit Syringe have any MRI safety restrictions?
No MRI safety restrictions are noted for the Merit Syringe. However, as with all medical devices, clinicians should verify compatibility with their specific MRI system and protocols before use.
What regulatory pathway does the Merit Syringe follow?
The Merit Syringe is regulated under the FDA’s 510(k) clearance process (K173601) and is classified as substantially equivalent to predicate devices. This pathway ensures compliance with U.S. medical device regulations for general hospital use.