Cleared Abbreviated

K140194 - NAMIC RCS SYRINGE

K140194 is an FDA 510(k) clearance for NAMIC RCS SYRINGE, manufactured by Navilyst Medical, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K140194 · Navilyst Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
77d
Days
Class 2
Risk

K140194 is an FDA 510(k) clearance for the NAMIC RCS SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on April 14, 2014 after a review of 77 days - a notably fast clearance cycle.

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 Navilyst Medical, Inc. devices

FDA 510(k) Submission Details - K140194

510(k) Number K140194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date April 14, 2014
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K140194.
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
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HARD PACK SYRINGE
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ETEX MIXING AND DELIVERY SYSTEM
K141245 · Etex Corporation · Jul 2014
SINGLE USE STERILE SYRINGE WITH NEEDLE
K133493 · Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · Mar 2014
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
K132011 · Aea Srl · Mar 2014
U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
K132553 · U&U Medical Technology Co, Ltd. · Feb 2014