Cleared Traditional

K891091 - TEMPTEK T-1000 THERAPEUTIC COOLING UNIT

K891091 is an FDA 510(k) clearance for TEMPTEK T-1000 THERAPEUTIC COOLING UNIT, manufactured by Temptek, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K891091 · Temptek, Inc. · Physical Medicine device
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Mar 1990
Decision
389d
Days
Class 2
Risk

K891091 is an FDA 510(k) clearance for the TEMPTEK T-1000 THERAPEUTIC COOLING UNIT. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Temptek, Inc. (Dallas, US). The FDA issued a Cleared decision on March 26, 1990 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Temptek, Inc. devices

FDA 510(k) Submission Details - K891091

510(k) Number K891091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date March 26, 1990
Days to Decision 389 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
274d slower than avg
Panel avg: 115d · This submission: 389d
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 43
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K891091.
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
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