Cleared Traditional

K945853 - THERMOTEK H-300

K945853 is an FDA 510(k) clearance for THERMOTEK H-300, manufactured by Thermotek, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K945853 · Thermotek, Inc. · Physical Medicine device
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Oct 1995
Decision
339d
Days
Class 2
Risk

K945853 is an FDA 510(k) clearance for the THERMOTEK H-300. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Thermotek, Inc. (Carrollton, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 339 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 Thermotek, Inc. devices

FDA 510(k) Submission Details - K945853

510(k) Number K945853 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 31, 1994
Decision Date October 05, 1995
Days to Decision 339 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
224d slower than avg
Panel avg: 115d · This submission: 339d
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 35
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K945853.
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EBICE
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THERMOCOOL SYSTEM
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BABYTHERM 8000 WB
K945467 · Drager, Inc. · Apr 1995