Cleared Traditional

K910061 - K-MODULE II HEAT THERAPY SYSTEM

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

K910061 · Baxter Healthcare Corp · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K910061

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
81d faster than avg
Panel avg: 116d · This submission: 35d
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 92
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K910061.
GOLDEN THERMAL(R)
K914182 · Seabrook Medical Systems, Inc. · Oct 1991
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
K911943 · Burke, Inc. · Jul 1991
THE BODY COOLER SYSTEM
K904998 · Costa / French · Jan 1991
PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
K902268 · Seabrook Medical Systems, Inc. · Jun 1990
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
K902269 · Seabrook Medical Systems, Inc. · Jun 1990
K910061 · K-MODULE II HEAT THERAPY SYSTEM
Download PDF Baxter Healthcare Corp