FDA product code MPO: Infant Heel Warmer (Chemical Heat Pack)
MPO is the FDA product code for infant heel warmer (chemical heat pack). It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel. FDA has cleared 11 510(k) submissions under MPO, 1 in the last five years, from 11 different applicants. The average 510(k) review took 114 days (median 90). FDA has posted 7 recalls for MPO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Infant Heel Warmer (Chemical Heat Pack) |
| Device class | Class I |
| Regulation | 21 CFR 890.5710 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MPO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 169 |
Compare with all 510(k) review times · Search every MPO clearance
Top MPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Biomedical | 1 | 2022-10-07 |
| CooperSurgical, Inc. | 1 | 2016-03-18 |
| Rapid Aid Corp. | 1 | 2015-05-27 |
| Denovo Products, LLC | 1 | 2011-04-08 |
| Shanghai Intco Medical Supply Co., Ltd. | 1 | 2006-09-19 |
6 more applicants have MPO clearances. See the full list in Caduvo.
Most recent MPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221154 | International Biomedical | Infant Heel WarmerTM; Heel Snuggler® | 2022-10-07 | 169 |
| K151845 | CooperSurgical, Inc. | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | 2016-03-18 | 255 |
| K150627 | Rapid Aid Corp. | Rapid Aid Instant Disposable Infant Heel Warmer | 2015-05-27 | 77 |
| K103549 | Denovo Products, LLC | DENOVO TEDDY GEL INFANT HEEL WARMER | 2011-04-08 | 126 |
| K053254 | Shanghai Intco Medical Supply Co., Ltd. | INFANT HEEL WARMER BY INTCO | 2006-09-19 | 302 |
Recalls for MPO devices
7 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-06-16.
| Year | Recalls |
|---|---|
| 2021 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code MPO?
MPO is the FDA product code for infant heel warmer (chemical heat pack). It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel.
What device class is MPO?
Class I, regulation 21 CFR 890.5710. Typical premarket route: 510(k).
How long does a 510(k) take for product code MPO?
Across 11 cleared submissions the average was 114 days from receipt to decision (median 90).
Which companies have the most MPO clearances?
International Biomedical (1); CooperSurgical, Inc. (1); Rapid Aid Corp. (1); Denovo Products, LLC (1); Shanghai Intco Medical Supply Co., Ltd. (1).
Have MPO devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2023-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code MPO
- Run a recall and safety report across every MPO manufacturer
- Watch product code MPO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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