510(k) · Cleared
Recalled · Class II · 2023Baxter Sodium Acetate Infant Heel Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Jun 6, 1996 as substantially equivalent to K950680 (Baxter Healthcare Corp, 1995) after a 76-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 1996
- Review
- 76 days
- Class
- Class I
- Product code
- MPO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950680 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK950680 Infant Heel WarmerBaxter Healthcare Corp · 1995
- This deviceK961154 Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996
- Descendant · cites it directly · 4 of its ownK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- Descendant · 3 generations on · 2 of its ownK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- Descendant · 4 generations on · 1 of its ownK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- Descendant · 5 generations on · 0 of its ownK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
Most influential descendants
Showing 5 of 5 · See all- K032989Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003 · cites it directly4descendants
- K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004 · 2 generations on3descendants
- K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015 · 3 generations on2descendants
- K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc. · 2016 · 4 generations on1descendant
- K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950680 | Infant Heel Warmer | Baxter Healthcare Corp | 1995 | — |
| 0 (this device) | K961154 | Baxter Sodium Acetate Infant Heel Warmer | Baxter Healthcare Corp | 1996 | — |
| +1 | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| +2 | K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid, Ltd. | 2004 | — |
| +3 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015 | — |
| +4 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| +5 | K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MPO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MPO device
- #1 K221154 Infant Heel WarmerTM; Heel Snuggler®score 5.6 · 6 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950680 | Infant Heel WarmerSummary page 1…cGaw Park, lllinois 60085 (847) 785-3322 February, 1996 Baxter Sodium Acetate Infant Heel Warmer™ Infant Heel Warmer Hot Disposable Pack Baxter Infant Heel Warmer™ (K950680) The Baxter Sodium Acetate Infant Heel Warmer™ is comprised of a polyethylene/BON pouch enclosing the phase change chemical and… | 1995 |
| * | — | PRISM Infant Heel Warmer Named without a submission number | |
| * | — | RECOVER® Infant Heel Warmer Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032989 | Medi-Heat Infant Heel Warmer | 2003 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2023 | Class II | Z-2147-2023 | Process control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MPO devicesMPO Infant Heel Warmer (Chemical Heat Pack): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MPO
Too few MPO 510(k)s in any year since 2007 to give a median.
Recalls per year · MPO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPO
15in 2025
MAUDE reports naming product code MPO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 56 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 1 | 20 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 74 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961154 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961154: Baxter Sodium Acetate Infant Heel Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026