Cleared Traditional

RE-HEATER, HOT PACK (K863654) - FDA 510(k) Clearance

Class I Physical Medicine device.

K863654 · K & L Ent. · Physical Medicine device
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Oct 1986
Decision
35d
Days
Class 1
Risk

K863654 is an FDA 510(k) clearance for the RE-HEATER, HOT PACK. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by K & L Ent. (Gardena, US). The FDA issued a Cleared decision on October 23, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5700 - 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 K & L Ent. devices

Submission Details

510(k) Number K863654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date October 23, 1986
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IME Pack, Hot Or Cold, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5700
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 - IME Pack, Hot Or Cold, Reusable

All 26
Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K863654.
THERMOELASTOMER HOT/COLD COMPRESS BK7186
K823649 · Fred Sammons, Inc. · Jan 1983
THERMOELASTOMER HOT/COLD COMPRESS-7187-
K823650 · Fred Sammons, Inc. · Jan 1983
ATTACH-A-PAK
K821636 · Fred Sammons, Inc. · Jun 1982
ACE COLD BANDAGE
K810402 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
REUSEABLE HOT & COLD PACKS
K810451 · Fred Sammons, Inc. · Mar 1981