Cleared Traditional

KACEY DISPOSABLE INFANT HEEL WARMER (K934673) - FDA 510(k) Clearance

Class I Physical Medicine device.

K934673 · K & C Medical, Inc. · Physical Medicine device
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Feb 1994
Decision
125d
Days
Class 1
Risk

K934673 is an FDA 510(k) clearance for the KACEY DISPOSABLE INFANT HEEL WARMER. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by K & C Medical, Inc. (Southport, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 125 days - within the typical 510(k) review window.

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: 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 K & C Medical, Inc. devices

Submission Details

510(k) Number K934673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date February 02, 1994
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
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 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K934673.
InfaTherm Disposable Infant Warming Mattress
K221653 · International Biomedical · Oct 2022
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K950680 · Baxter Healthcare Corp · Aug 1995
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