Cleared Traditional

K952038 - CLEAN-CUFF

K952038 is the FDA 510(k) clearance for CLEAN-CUFF by Instrumed, Inc.. It is a Class 1 General & Plastic Surgery device (product code KCY) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K952038 · Instrumed, Inc. · General & Plastic Surgery device
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Jul 1995
Decision
71d
Days
Class 1
Risk

K952038 is an FDA 510(k) clearance for the CLEAN-CUFF. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Instrumed, Inc. (Bothell, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 71 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 Instrumed, Inc. devices

Submission Details

510(k) Number K952038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date July 11, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
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

All 8
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K952038.
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · Smith & Nephew Richards, Inc. · Jan 1996
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · Deroyal Industries, Inc. · Sep 1995
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · Arthrex, Inc. · Mar 1994
PRESSURE SENTRY TOURNIQUET
K840206 · Richards Medical Co., Inc. · Apr 1984
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc. · Oct 1979