Cleared Traditional

K943497 - CONTRAST 7000 THERAPY SYSTEM

K943497 is an FDA 510(k) clearance for CONTRAST 7000 THERAPY SYSTEM, manufactured by Burke Neutech, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K943497 · Burke Neutech, Inc. · Physical Medicine device
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Jun 1995
Decision
323d
Days
Class 2
Risk

K943497 is an FDA 510(k) clearance for the CONTRAST 7000 THERAPY SYSTEM. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Burke Neutech, Inc. (Largo, US). The FDA issued a Cleared decision on June 7, 1995 after a review of 323 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.

FDA 510(k) Submission Details - K943497

510(k) Number K943497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date June 07, 1995
Days to Decision 323 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
207d slower than avg
Panel avg: 116d · This submission: 323d
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 88
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K943497.
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K934262 · Marley Electric Heating Co. · Apr 1995
DELTA THERM COLD THERAPY SYSTEM
K945399 · Deltatherm · Mar 1995
K943497 · CONTRAST 7000 THERAPY SYSTEM
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