Cleared Abbreviated

K171362 - Merit Syringe

K171362 is an FDA 510(k) clearance for Merit Syringe, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K171362 · Merit Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
90d
Days
Class 2
Risk

K171362 is an FDA 510(k) clearance for the Merit Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 7, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K171362

510(k) Number K171362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date August 07, 2017
Days to Decision 90 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 566
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K171362.
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
K170900 · Intervene Group, Ltd. · Nov 2017
MHC Standard and NRFit Tip Syringes
K171131 · Mazza Healthcare, LLC · Nov 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
K171805 · Conceptomed AS · Sep 2017
Graftgun Universal Graft Delivery System
K170675 · SurGenTec, LLC · Jul 2017
CompuFlo Epidural Computer Controlled Anesthesia System
K161883 · Milestone Scientific, Inc. · Jun 2017
BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle
K170386 · Becton, Dickinson Company · Apr 2017