Cleared Traditional

K950395 - THERMOCOOL SYSTEM

K950395 is an FDA 510(k) clearance for THERMOCOOL SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K950395 · Zimmer, Inc. · Physical Medicine device
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Aug 1995
Decision
198d
Days
Class 2
Risk

K950395 is an FDA 510(k) clearance for the THERMOCOOL SYSTEM. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 198 days - an extended review 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: 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K950395

510(k) Number K950395 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 01, 1995
Decision Date August 18, 1995
Days to Decision 198 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
83d slower than avg
Panel avg: 115d · This submission: 198d
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 41
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K950395.
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EBICE
K945067 · Electro-Biology, Inc. · Feb 1995
INCARE HOT/ICE COLD THERAPY COOLER
K944971 · Hollister, Inc. · Jan 1995