Cleared Traditional

K853537 - VELCRO TOURNIQUET

K853537 is an FDA 510(k) clearance for VELCRO TOURNIQUET, manufactured by Cp Medical. The device is a Class 1 General & Plastic Surgery device with product code GAX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K853537 · Cp Medical · General & Plastic Surgery device
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Sep 1985
Decision
20d
Days
Class 1
Risk

K853537 is an FDA 510(k) clearance for the VELCRO TOURNIQUET. Classified as Tourniquet, Nonpneumatic (product code GAX), Class I - General Controls.

Submitted by Cp Medical (Costa Mesa, US). The FDA issued a Cleared decision on September 12, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5900 - 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 - K853537

510(k) Number K853537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date September 12, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

GAX Device Classification - Class 1, General Controls

Product Code GAX Tourniquet, Nonpneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5900
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 - GAX Tourniquet, Nonpneumatic

All 19
Devices cleared under the same product code (GAX) and FDA review panel - the closest regulatory comparables to K853537.
KINDERWRAP
K872003 · The Kinder Co. · Jun 1987
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
K864897 · Dale Medical Products, Inc. · Jan 1987
FINGER TOURNIQUETTE
K853472 · Joseph B. Marogil · Oct 1985
CATAPRESS TOURNIGUET
K852277 · Boehringer Ingelheim Pharmaceuticals, Inc. · Jun 1985
TOURNIQUET
K851482 · Polymer Technology Corp. · Apr 1985
ELASTIC BANDAGE
K843056 · Sterile Medical Systems · Dec 1984
K853537 · VELCRO TOURNIQUET
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