K151845 is an FDA 510(k) clearance for the Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418). This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5710.
| 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 |
| Product Code | MPO — Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |