Cleared Traditional

COLD PACK (K923627) - FDA 510(k) Clearance

Class I Physical Medicine device.

K923627 · Friendmed Products · Physical Medicine device
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Apr 1993
Decision
267d
Days
Class 1
Risk

K923627 is an FDA 510(k) clearance for the COLD PACK. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Friendmed Products (Athens, US). The FDA issued a Cleared decision on April 14, 1993 after a review of 267 days - an extended review 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: 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 Friendmed Products devices

Submission Details

510(k) Number K923627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date April 14, 1993
Days to Decision 267 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
152d slower than avg
Panel avg: 115d · This submission: 267d
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 K923627.
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