Cleared Traditional

K915196 - INCARE HOT/ICE SYSTEM 3

K915196 is an FDA 510(k) clearance for INCARE HOT/ICE SYSTEM 3, manufactured by Hollister, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K915196 · Hollister, Inc. · Physical Medicine device
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Feb 1992
Decision
76d
Days
Class 2
Risk

K915196 is an FDA 510(k) clearance for the INCARE HOT/ICE SYSTEM 3. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 3, 1992 after a review of 76 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K915196

510(k) Number K915196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date February 03, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
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 23
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K915196.
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
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