Cleared Traditional

K801272 - TECNOL QUICK RELEASE LIMB HOLDER

K801272 is an FDA 510(k) clearance for TECNOL QUICK RELEASE LIMB HOLDER, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801272 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Jun 1980
Decision
20d
Days
Class 1
Risk

K801272 is an FDA 510(k) clearance for the TECNOL QUICK RELEASE LIMB HOLDER. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Walker, US). The FDA issued a Cleared decision on June 17, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - the FDA general hospital 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K801272

510(k) Number K801272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date June 17, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 33
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K801272.
SAFETY VEST
K962429 · Johnson & Johnson Professionals, Inc. · Sep 1996
BED PRODUCTS
K850470 · Abco Dealers, Inc. · Apr 1985
HEAD PROTECTOR
K812473 · Maddak, Inc. · Dec 1981
TECNOL BODY HOLDER
K790699 · Tecnol New Jersey Wound Care, Inc. · Jun 1979
BK-5098 TILT TABLE STRAP
K790172 · Fred Sammons, Inc. · Feb 1979
RESTRAINT, PROTECTIVE
K780232 · Biomet, Inc. · Feb 1978