Cleared Traditional

K921540 - COOLING/HEATING THERAPY DEVICE

K921540 is an FDA 510(k) clearance for COOLING/HEATING THERAPY DEVICE, manufactured by Tempacure Home Care. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K921540 · Tempacure Home Care · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
111d
Days
Class 2
Risk

K921540 is an FDA 510(k) clearance for the COOLING/HEATING THERAPY DEVICE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Tempacure Home Care (Manassas, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Tempacure Home Care devices

FDA 510(k) Submission Details - K921540

510(k) Number K921540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date July 21, 1992
Days to Decision 111 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 44
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K921540.
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
SUR FLO THERMAL THERAPY PADS
K930634 · Buckman Co., Inc. · Nov 1993
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
K-MODULE II HEAT THERAPY SYSTEM
K910061 · Baxter Healthcare Corp · Feb 1991