Cleared Traditional

OMNI COLD GEL PACKS (K954877) - FDA 510(k) Clearance

Class I Physical Medicine device.

K954877 · Omni Therm, Inc. · Physical Medicine device
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Feb 1996
Decision
112d
Days
Class 1
Risk

K954877 is an FDA 510(k) clearance for the OMNI COLD GEL PACKS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Omni Therm, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 13, 1996 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - 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 Omni Therm, Inc. devices

Submission Details

510(k) Number K954877 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 24, 1995
Decision Date February 13, 1996
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IMD Pack, Hot Or Cold, Disposable

All 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K954877.
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K850637 · Travenol Laboratories, S.A. · Apr 1985