Cleared Traditional

K822553 - PRESSURE-QUET TOURNIQUET

K822553 is an FDA 510(k) clearance for PRESSURE-QUET TOURNIQUET, manufactured by Nutec Med, Inc.. The device is a Class 1 Hematology device with product code GAX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K822553 · Nutec Med, Inc. · Hematology device
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Sep 1982
Decision
24d
Days
Class 1
Risk

K822553 is an FDA 510(k) clearance for the PRESSURE-QUET TOURNIQUET. Classified as Tourniquet, Nonpneumatic (product code GAX), Class I - General Controls.

Submitted by Nutec Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 878.5900 - the FDA hematology 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 - K822553

510(k) Number K822553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date September 17, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
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 17
Devices cleared under the same product code (GAX) and FDA review panel - the closest regulatory comparables to K822553.
ELASTIC BANDAGE
K843056 · Sterile Medical Systems · Dec 1984
DISPOSIQUET A DISPOS. TOURNIQUET
K840489 · Med Lab Products · Mar 1984
TOURNIQUET/LATEX TOURNIQUET
K830467 · Primeline Industries, Inc. · Mar 1983
LATEX PENROSE DRAIN TUBING
K821700 · Abco Dealers, Inc. · Jun 1982
CONPHAR VELCRO TOUNIGUER
K803142 · Conphar, Inc. · Jan 1981
VELKET TOURNIQUET
K780594 · Abco Dealers, Inc. · Jun 1978
K822553 · PRESSURE-QUET TOURNIQUET
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