Cleared Traditional

K032989 - MEDI-HEAT INFANT HEEL WARMER

K032989 is an FDA 510(k) clearance for MEDI-HEAT INFANT HEEL WARMER, manufactured by Mediheat, Inc.. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K032989 · Mediheat, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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Oct 2003
Decision
28d
Days
Class 1
Risk

K032989 is an FDA 510(k) clearance for the MEDI-HEAT INFANT HEEL WARMER. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Mediheat, Inc. (Dalton, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 28 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 Mediheat, Inc. devices

FDA 510(k) Submission Details - K032989

510(k) Number K032989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date October 22, 2003
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

MPO Device Classification - Class 1, General Controls

Product Code MPO Infant Heel Warmer (chemical Heat Pack)
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 - MPO Infant Heel Warmer (chemical Heat Pack)

All 7
Devices cleared under the same product code (MPO) and FDA review panel - the closest regulatory comparables to K032989.
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · CooperSurgical, Inc. · Mar 2016
DENOVO TEDDY GEL INFANT HEEL WARMER
K103549 · Denovo Products, LLC · Apr 2011
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004
RECOVER INFANT HEEL WARMER (5100)
K964523 · Florida Medical Industries, Inc. · Feb 1997
BAXTER SODIUM ACETATE INFANT HEEL WARMER
K961154 · Baxter Healthcare Corp · Jun 1996
DEROYAL INDUSTRIES INFANT HEEL WARMER
K954716 · Debusk Knitting Mills, Div. Deroyal Industries · Jan 1996