Cleared Traditional

K221154 - Infant Heel WarmerTM

Also marketed or referenced as:
Heel Snuggler®

K221154 is an FDA 510(k) clearance for Infant Heel WarmerTM, manufactured by International Biomedical. The device is a Class 1 Physical Medicine device with product code MPO cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K221154 · International Biomedical · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
169d
Days
Class 1
Risk

K221154 is an FDA 510(k) clearance for the Infant Heel WarmerTM. Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 7, 2022 after a review of 169 days - an extended review 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: 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 International Biomedical devices

FDA 510(k) Submission Details - K221154

510(k) Number K221154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 116d · This submission: 169d
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 8
Devices cleared under the same product code (MPO) and FDA review panel - the closest regulatory comparables to K221154.
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
HEEL SNUGGLER, MODEL 99047
K040044 · Respironics, Inc. · Jan 2004
RECOVER INFANT HEEL WARMER (5100)
K964523 · Florida Medical Industries, Inc. · Feb 1997