Cleared Traditional

HOT OR COLD PACK (THERMIPAQ) (K921446) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

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 K921446.
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