Cleared Traditional

K940336 - CERTI HEAT INSTANT HEAT COMPRESS

K940336 is an FDA 510(k) clearance for CERTI HEAT INSTANT HEAT COMPRESS, manufactured by Certified Safety Mfg., Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K940336 · Certified Safety Mfg., Inc. · Physical Medicine device
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Mar 1994
Decision
41d
Days
Class 1
Risk

K940336 is an FDA 510(k) clearance for the CERTI HEAT INSTANT HEAT COMPRESS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 41 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K940336

510(k) Number K940336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date March 07, 1994
Days to Decision 41 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
75d faster than avg
Panel avg: 116d · This submission: 41d
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 46
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K940336.
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994
OMNI WARM GEL PACKS
K936084 · Omni Therm, Inc. · Mar 1994
INSTANT HOT OR COLD DISPOSABLE PACK
K935569 · Cryopak Industries, Inc. · Mar 1994
TRANSWARMER
K934631 · Prism Technologies, Inc. · Feb 1994
KACEY DISPOSABLE INFANT HEEL WARMER
K934673 · K & C Medical, Inc. · Feb 1994
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
K940336 · CERTI HEAT INSTANT HEAT COMPRESS
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