Cleared Traditional

K950395 - THERMOCOOL SYSTEM

K950395 is the FDA 510(k) clearance for THERMOCOOL SYSTEM by Zimmer, Inc.. It is a Class 2 Physical Medicine device (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

Submission Details

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.

Device Classification

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 16
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K950395.
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K964057 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE LITE MACHINE
K962537 · Hollister, Inc. · Nov 1996
INCARE HOT/ICE COLD THERAPY COOLER
K944971 · Hollister, Inc. · Jan 1995
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
SUR FLO THERMAL THERAPY PADS
K930634 · Buckman Co., Inc. · Nov 1993