Cleared Traditional

K890924 - THERMO-PACK

K890924 is the FDA 510(k) clearance for THERMO-PACK by Medical Manufacturers, Inc.. It is a Class 1 Physical Medicine device (product code IMD) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K890924 · Medical Manufacturers, Inc. · Physical Medicine device
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Mar 1989
Decision
18d
Days
Class 1
Risk

K890924 is an FDA 510(k) clearance for the THERMO-PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Medical Manufacturers, Inc. (Englewood, US). The FDA issued a Cleared decision on March 14, 1989 after a review of 18 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 Medical Manufacturers, Inc. devices

Submission Details

510(k) Number K890924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1989
Decision Date March 14, 1989
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 10
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K890924.
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
EXOTHERMIC HEATING PAD
K850637 · Travenol Laboratories, S.A. · Apr 1985
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