Cleared Traditional

K850637 - EXOTHERMIC HEATING PAD

K850637 is the FDA 510(k) clearance for EXOTHERMIC HEATING PAD by Travenol Laboratories, S.A.. It is a Class 1 Physical Medicine device (product code IMD) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K850637 · Travenol Laboratories, S.A. · Physical Medicine device
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Apr 1985
Decision
65d
Days
Class 1
Risk

K850637 is an FDA 510(k) clearance for the EXOTHERMIC HEATING PAD. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 65 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.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K850637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date April 25, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
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 19
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K850637.
ANAGO DISPOSABLE INSTANT COLD PACK
K926590 · Anago, Inc. · May 1993
CURAD KID SIZE INSTANT COLD PACK
K920252 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1992
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982
BK-7182 INSTANT COLD PACK
K813628 · Fred Sammons, Inc. · Jan 1982
CURITY PERINEAL WARM PACK
K810692 · The Kendal Co. · Mar 1981