Cleared Traditional

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

K151845 · CooperSurgical, Inc. · Physical Medicine

Mar 2016

Decision

255d

Days

Class 1

Risk

About This 510(k) Submission

K151845 is an FDA 510(k) clearance for the Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418), a Infant Heel Warmer (chemical Heat Pack) (Class I — General Controls, product code MPO), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on March 18, 2016, 255 days after receiving the submission on July 7, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K151845 FDA.gov
FDA Decision	Cleared 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