Cleared Traditional

K955552 - EXPRESSAIRE TORUNIQUET SYSTEM

K955552 is an FDA 510(k) clearance for EXPRESSAIRE TORUNIQUET SYSTEM, manufactured by Smith & Nephew Richards, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K955552 · Smith & Nephew Richards, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
31d
Days
Class 1
Risk

K955552 is an FDA 510(k) clearance for the EXPRESSAIRE TORUNIQUET SYSTEM. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 31 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 Smith & Nephew Richards, Inc. devices

FDA 510(k) Submission Details - K955552

510(k) Number K955552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date January 05, 1996
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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 18
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K955552.
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K933994 · Arthrex, Inc. · Mar 1994