Cleared Traditional

K891151 - COOL 'N HEAT MACHINE

K891151 is an FDA 510(k) clearance for COOL 'N HEAT MACHINE, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K891151 · Kinetic Concepts, Inc. · Physical Medicine device
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Apr 1989
Decision
34d
Days
Class 2
Risk

K891151 is an FDA 510(k) clearance for the COOL 'N HEAT MACHINE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 6, 1989 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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.

View all Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K891151

510(k) Number K891151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date April 06, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 25
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K891151.
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · Baxter Healthcare Corp · Feb 1991
GRAND COOLING MACHINE
K891152 · Kinetic Concepts, Inc. · Mar 1989
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255 · Concept, Inc. · Nov 1988
MUL-T-PAD
K832819 · Gaymar Industries, Inc. · Sep 1983