# K961154: Baxter Sodium Acetate Infant Heel Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 6, 1996 after 76 days
- Product code: MPO (Infant Heel Warmer (Chemical Heat Pack))
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950680 (1995). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950680: Infant Heel Warmer, Baxter Healthcare Corp (1995) Summary page 1.
- (no number) PRISM Infant Heel Warmer: named in the summary without a submission number
- (no number) RECOVER® Infant Heel Warmer: named in the summary without a submission number

## Most influential descendants
- K032989: Medi-Heat Infant Heel Warmer (2003), 4 descendants of its own
- K040856: Rapid Aid Instant Disposable Infant Heel Warmer (2004), 3 descendants of its own
- K150627: Rapid Aid Instant Disposable Infant Heel Warmer (2015), 2 descendants of its own
- K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (2016), 1 descendant of its own
- K221154: Infant Heel WarmerTM; Heel Snuggler® (2022), 0 descendants of its own

## Recalls of this device
- Jun 16, 2023 · Class II · Z-2147-2023: Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

## Indications for use
The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant’s heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.

Source page: https://510kreport.com/device/K961154
Methodology: https://510kreport.com/methodology