Cleared Traditional

K103549 - DENOVO TEDDY GEL INFANT HEEL WARMER

K103549 is an FDA 510(k) clearance for DENOVO TEDDY GEL INFANT HEEL WARMER, manufactured by Denovo Products, LLC. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K103549 · Denovo Products, LLC · Physical Medicine device
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Apr 2011
Decision
126d
Days
Class 1
Risk

K103549 is an FDA 510(k) clearance for the DENOVO TEDDY GEL INFANT HEEL WARMER. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by Denovo Products, LLC (Fort Myers, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 126 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 Denovo Products, LLC devices

FDA 510(k) Submission Details - K103549

510(k) Number K103549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date April 08, 2011
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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)

Devices cleared under the same product code (MPO) and FDA review panel - the closest regulatory comparables to K103549.
Infant Heel WarmerTM
K221154 · International Biomedical · Oct 2022
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · CooperSurgical, Inc. · Mar 2016
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