Cleared Traditional

K850637 - EXOTHERMIC HEATING PAD

K850637 is an FDA 510(k) clearance for EXOTHERMIC HEATING PAD, manufactured by Travenol Laboratories, S.A.. The device is a Class 1 Physical Medicine device with 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.

FDA 510(k) Submission Details - K850637

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
51d faster than avg
Panel avg: 116d · This submission: 65d
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 80
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K850637.
ALLY PORTABLE NOT PACK/PAD DISPOSABLE
K853045 · Actin International, Inc. · Sep 1985
HOT PACK
K852610 · Oriental Medical Supplies, Inc. · Aug 1985
MARUKYR-BAN / HOT OR HEAT PACK
K850566 · Oriental Medical Supplies, Inc. · May 1985
EIXO THERMUS HEATING PADS
K844224 · Eixo Thermus · Nov 1984
SPENCO CRYOPRESS
K820906 · Spenco Medical Corp. · May 1982
COMPRES PORTABLE HEAT PADS
K821046 · S.C. Johnson & Son, Inc. · Apr 1982
K850637 · EXOTHERMIC HEATING PAD
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