Cleared Traditional

K961425 - BIO COMPRESSION COLD FLO

K961425 is an FDA 510(k) clearance for BIO COMPRESSION COLD FLO, manufactured by Bio Compression Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K961425 · Bio Compression Systems, Inc. · Physical Medicine device
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Oct 1996
Decision
199d
Days
Class 2
Risk

K961425 is an FDA 510(k) clearance for the BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUE.... Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Bio Compression Systems, Inc. (Broadview Heights, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 199 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 Bio Compression Systems, Inc. devices

FDA 510(k) Submission Details - K961425

510(k) Number K961425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1996
Decision Date October 28, 1996
Days to Decision 199 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
84d slower than avg
Panel avg: 115d · This submission: 199d
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 26
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K961425.
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