Cleared Traditional

K791675 - KWICK KOOLER

K791675 is an FDA 510(k) clearance for KWICK KOOLER, manufactured by Stahlex Corp.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K791675 · Stahlex Corp. · Physical Medicine device
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Sep 1979
Decision
7d
Days
Class 1
Risk

K791675 is an FDA 510(k) clearance for the KWICK KOOLER. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Stahlex Corp. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 - K791675

510(k) Number K791675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1979
Decision Date September 04, 1979
Days to Decision 7 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 116d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 80
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K791675.
CURITY PERINEAL WARM PACK
K810692 · The Kendal Co. · Mar 1981
CURITY PERINEAL COLD PACK
K810693 · The Kendal Co. · Mar 1981
INSTANT HOT & COLD PACKS
K790993 · Chase Mfg. Co. · Sep 1979
TULANE HEAT-PACK
K790480 · Tulane · Apr 1979
BODY WARMER
K780426 · Q-Matic Corp. · Apr 1978
COLD PACK
K780603 · Abco Dealers, Inc. · Apr 1978
K791675 · KWICK KOOLER
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