Cleared Traditional

K910061 - K-MODULE II HEAT THERAPY SYSTEM

K910061 is the FDA 510(k) clearance for K-MODULE II HEAT THERAPY SYSTEM by Baxter Healthcare Corp. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K910061 · Baxter Healthcare Corp · Physical Medicine device
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Feb 1991
Decision
35d
Days
Class 2
Risk

K910061 is an FDA 510(k) clearance for the K-MODULE II HEAT THERAPY SYSTEM. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on February 13, 1991 after a review of 35 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K910061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date February 13, 1991
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K910061.
MEDICOOL
K923643 · Micromedic Systems · Mar 1993
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
COOL 'N HEAT MACHINE
K891151 · Kinetic Concepts, Inc. · Apr 1989
GRAND COOLING MACHINE
K891152 · Kinetic Concepts, Inc. · Mar 1989
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255 · Concept, Inc. · Nov 1988