Cleared Traditional

K921446 - HOT OR COLD PACK (THERMIPAQ)

K921446 is an FDA 510(k) clearance for HOT OR COLD PACK (THERMIPAQ), manufactured by Thermionics Corp.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K921446 · Thermionics Corp. · Physical Medicine device
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Jul 1992
Decision
108d
Days
Class 1
Risk

K921446 is an FDA 510(k) clearance for the HOT OR COLD PACK (THERMIPAQ). Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Thermionics Corp. (Springfield, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermionics Corp. devices

FDA 510(k) Submission Details - K921446

510(k) Number K921446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date July 13, 1992
Days to Decision 108 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

IME Device Classification - Class 1, General Controls

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 10
Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K921446.
SUBOCCIPITAL ICE PILLOW
K882413 · Ferguson Medical · Nov 1988
NICE PACK
K832193 · Universal Medical Instrument Corp. · Aug 1983
THERMOELASTOMER HOT/COLD COMPRESS BK7186
K823649 · Fred Sammons, Inc. · Jan 1983
THERMOELASTOMER HOT/COLD COMPRESS-7187-
K823650 · Fred Sammons, Inc. · Jan 1983
HOT/COLD PACK HOLDERS
K823814 · Danek Medical, Inc. · Jan 1983
ATTACH-A-PAK
K821636 · Fred Sammons, Inc. · Jun 1982