Product code MPO— Physical Medicine
BAXTER SODIUM ACETATE INFANT HEEL WARMER
- Classification name
- Infant Heel Warmer (Chemical Heat Pack)
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code MPO
FDA has cleared devices under product code MPO between 1996 and 2022, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2022
- 2016
- 2015
- 2011
- 2006
- 2004
- 2003
- 1997
- 1996
Top applicants under product code MPO
Recent clearances under product code MPO
- K221154 — Infant Heel WarmerTM; Heel Snuggler®
- K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
- K150627 — Rapid Aid Instant Disposable Infant Heel Warmer
- K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER
- K053254 — INFANT HEEL WARMER BY INTCO
- K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
- K040044 — HEEL SNUGGLER, MODEL 99047
- K032989 — MEDI-HEAT INFANT HEEL WARMER
- K964523 — RECOVER INFANT HEEL WARMER (5100)
- K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER
- K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER
Data sourced from openFDA. This site is unofficial and independent of the FDA.