Cleared Traditional

Infant Heel WarmerTM; Heel Snuggler?

K221154 · International Biomedical · Physical Medicine
Oct 2022
Decision
169d
Days
Class 1
Risk

About This 510(k) Submission

K221154 is an FDA 510(k) clearance for the Infant Heel WarmerTM; Heel Snuggler?, a Infant Heel Warmer (chemical Heat Pack) (Class I — General Controls, product code MPO), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 7, 2022, 169 days after receiving the submission on April 21, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K221154 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2022
Decision Date October 07, 2022
Days to Decision 169 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code MPO — Infant Heel Warmer (chemical Heat Pack)
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5710

Similar Devices — MPO Infant Heel Warmer (chemical Heat Pack)

All 10
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
K151845 · CooperSurgical, Inc. · Mar 2016
Rapid Aid Instant Disposable Infant Heel Warmer
K150627 · Rapid Aid Corp. · May 2015
DENOVO TEDDY GEL INFANT HEEL WARMER
K103549 · Denovo Products, LLC · Apr 2011
INFANT HEEL WARMER BY INTCO
K053254 · Shanghai Intco Medical Supply Co., Ltd. · Sep 2006
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
K040856 · Rapid Aid , Ltd. · May 2004
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004