Cleared Traditional

K936084 - OMNI WARM GEL PACKS

K936084 is an FDA 510(k) clearance for OMNI WARM GEL PACKS, manufactured by Omni Therm, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K936084 · Omni Therm, Inc. · Physical Medicine device
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Mar 1994
Decision
100d
Days
Class 1
Risk

K936084 is an FDA 510(k) clearance for the OMNI WARM 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 March 31, 1994 after a review of 100 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

FDA 510(k) Submission Details - K936084

510(k) Number K936084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1993
Decision Date March 31, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

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 34
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K936084.
OMNI COLD GEL PACKS
K954877 · Omni Therm, Inc. · Feb 1996
INFANT HEEL WARMER
K950680 · Baxter Healthcare Corp · Aug 1995
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994
CERTI HEAT INSTANT HEAT COMPRESS
K940336 · Certified Safety Mfg., Inc. · Mar 1994
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
ANAGO FEM-COOL/FEM-COOL PETITE
K926137 · Anago, Inc. · May 1993