Cleared Traditional

K151845 - Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K151845 · CooperSurgical, Inc. · Physical Medicine device
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Mar 2016
Decision
255d
Days
Class 1
Risk

K151845 is an FDA 510(k) clearance for the Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418). Classified as Infant Heel Warmer (chemical Heat Pack) (product code MPO), Class I - General Controls.

Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on March 18, 2016 after a review of 255 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 CooperSurgical, Inc. devices

Submission Details

510(k) Number K151845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2015
Decision Date March 18, 2016
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
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.