K221154 is an FDA 510(k) clearance for the Infant Heel WarmerTM. This device is classified as a Infant Heel Warmer (chemical Heat Pack) (Class I - General Controls, product code MPO).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 7, 2022, 169 days after receiving the submission on April 21, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 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 |
| Product Code | MPO - Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |