Cleared Traditional

K931203 - COOL-AID

K931203 is an FDA 510(k) clearance for COOL-AID, manufactured by Seabrook Medical Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K931203 · Seabrook Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
350d
Days
Class 2
Risk

K931203 is an FDA 510(k) clearance for the COOL-AID. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Seabrook Medical Systems, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 350 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 Seabrook Medical Systems, Inc. devices

FDA 510(k) Submission Details - K931203

510(k) Number K931203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date February 22, 1994
Days to Decision 350 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 115d · This submission: 350d
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 K931203.
BABYTHERM 8000 WB
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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
MEDICOOL
K923643 · Micromedic Systems · Mar 1993