Cleared Traditional

K141762 - PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM

K141762 is the FDA 510(k) clearance for PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM by Biomet, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K141762 · Biomet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
57d
Days
Class 2
Risk

K141762 is an FDA 510(k) clearance for the PERFUSE PERCUTANEOUS DECOMPRESSION 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 August 27, 2014 after a review of 57 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K141762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date August 27, 2014
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 249
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K141762.
BD Single Use, Hypodermic Syringe
K151766 · Becton, Dickinson and Company · Sep 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
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