MPO
11 FDA 510(k) clearances · Product code
90 daysmedian time to decision
255 days90th percentile
11clearances measured
FDA profile
- Official device name
- Infant Heel Warmer (Chemical Heat Pack)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2020: 53 · 2021: 20 · 2022: 61 · 2023: 74 · 2024: 25 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Infant Heel WarmerTM; Heel Snuggler® (K221154) | International Biomedical | 2022-10-07 |
| Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845) | CooperSurgical, Inc. | 2016-03-18 |
| Rapid Aid Instant Disposable Infant Heel Warmer (K150627) | Rapid Aid Corp. | 2015-05-27 |
| DENOVO TEDDY GEL INFANT HEEL WARMER (K103549) | Denovo Products, LLC | 2011-04-08 |
| INFANT HEEL WARMER BY INTCO (K053254) | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (K040856) | Rapid Aid , Ltd. | 2004-05-03 |
| HEEL SNUGGLER, MODEL 99047 (K040044) | Respironics, Inc. | 2004-01-27 |
| MEDI-HEAT INFANT HEEL WARMER (K032989) | Mediheat, Inc. | 2003-10-22 |
| RECOVER INFANT HEEL WARMER (5100) (K964523) | Florida Medical Industries, Inc. | 1997-02-10 |
| BAXTER SODIUM ACETATE INFANT HEEL WARMER (K961154) | Baxter Healthcare Corp | 1996-06-06 |
| DEROYAL INDUSTRIES INFANT HEEL WARMER (K954716) | Debusk Knitting Mills, Div. Deroyal Industries | 1996-01-11 |
Track MPO automatically
Every clearance here is in the API, with alerts when new ones post.