Cleared Traditional

K954201 - BUONAFEDE PNEUMATIC SLEEVE

K954201 is an FDA 510(k) clearance for BUONAFEDE PNEUMATIC SLEEVE, manufactured by Promedic, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K954201 · Promedic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K954201

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

KCY Device Classification - Class 1, General Controls

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

All 22
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K954201.
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
TOURNIQUET CUFF
K012632 · Medical Instruments Technology, Inc. · Oct 2001
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · Smith & Nephew Richards, Inc. · Jan 1996
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · Deroyal Industries, Inc. · Sep 1995
ACCUTEST
K940615 · Instrumed, Inc. · May 1995
TECNADYNE T-CUFF
K942303 · Technadyne Scientific, Inc. · Jul 1994