Cleared Traditional

BUONAFEDE PNEUMATIC SLEEVE (K954201) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K954201 · Promedic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
64d
Days
Class 1
Risk

K954201 is an FDA 510(k) clearance for the BUONAFEDE PNEUMATIC SLEEVE. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Promedic, Inc. (Sturgis, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery 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 Promedic, Inc. devices

Submission Details

510(k) Number K954201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date November 09, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KCY Tourniquet, Pneumatic

Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K954201.
ATS 5000 Automatic Tourniquet Instrument
K202919 · Mcewen and Associates Consulting , Ltd. · May 2021
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc. · Aug 2013
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · Arthrex, Inc. · Mar 1994
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc. · Oct 1979