Cleared Traditional

K221154 - Infant Heel WarmerTM (FDA 510(k) Clearance)

Also includes:
Heel Snuggler®

Class I Physical Medicine device.

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

Submission Details

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
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.