Cleared Traditional

K091722 - COAXIAL APPLICATOR SYSTEM

K091722 is the FDA 510(k) clearance for COAXIAL APPLICATOR SYSTEM by Biomet, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K091722 · Biomet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
274d
Days
Class 2
Risk

K091722 is an FDA 510(k) clearance for the COAXIAL APPLICATOR SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 12, 2010 after a review of 274 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K091722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date March 12, 2010
Days to Decision 274 days
Submission Type Traditional
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
145d slower than avg
Panel avg: 129d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 279
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K091722.
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771 · Becton, Dickinson and Company · May 2011
EPIDRUM
K093863 · Exmoor Plastics , Ltd. · May 2010
BD FLU+ SYRINGE
K091377 · Becton, Dickinson & CO · Jul 2009
MICROMYST APPLICATOR, MODEL 20-5000
K082454 · Covidien · Nov 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008