Cleared Special

K122373 - NEOMED ORAL/ENTERAL SYRINGE

K122373 is the FDA 510(k) clearance for NEOMED ORAL/ENTERAL SYRINGE by Neomed, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 45-day FDA review.

K122373 · Neomed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
45d
Days
Class 2
Risk

K122373 is an FDA 510(k) clearance for the NEOMED ORAL/ENTERAL SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Neomed, Inc. (Woodstock, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neomed, Inc. devices

Submission Details

510(k) Number K122373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date September 20, 2012
Days to Decision 45 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K122373.
NAMIC RCS SYRINGE
K140194 · Navilyst Medical, Inc. · Apr 2014
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · Nipro Medical Corporation · Aug 2013
MONOJECT 12ML SYRINGE
K130049 · Nipro Medical Corporation · Feb 2013
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011