510(k) · Cleared
ClearedInfant Heel Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · IMD Pack, Hot Or Cold, Disposable
Cleared on Aug 23, 1995 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Aug 23, 1995
- Review
- 190 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK950680 Infant Heel WarmerBaxter Healthcare Corp · 1995
- Descendant · cites it directly · 5 of its ownK961154 Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996 · Recalled
- Descendant · 2 generations on · 4 of its ownK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- Descendant · 3 generations on · 3 of its ownK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- Descendant · 4 generations on · 2 of its ownK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- Descendant · cites it directly · 2 of its ownK982652 Allegiance Porta-Warm MattressAllegiance Healthcare Corp. · 1999
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K961154Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996 · cites it directly5descendants
- K032989Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003 · 2 generations on4descendants
- K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004 · 3 generations on3descendants
- K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015 · 4 generations on2descendants
- K982652Allegiance Porta-Warm MattressAllegiance Healthcare Corp. · 1999 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950680 | Infant Heel Warmer | Baxter Healthcare Corp | 1995 | — |
| +1 | K961154 | Baxter Sodium Acetate Infant Heel Warmer | Baxter Healthcare Corp | 1996 | 1 |
| +2 | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| +3 | K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid, Ltd. | 2004 | — |
| +4 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015 | — |
| +1 | K982652 | Allegiance Porta-Warm Mattress | Allegiance Healthcare Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMD? 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 IMD device
- #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961154 (Baxter Healthcare Corp, 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All IMD devicesIMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMD
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IMD
Too few IMD 510(k)s in any year since 2007 to give a median.
Recalls per year · IMD
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMD
66in 2025
MAUDE reports naming product code IMD, 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 | 1 | — | 0 | 211 |
| 2008 | 1 | — | 4 | 804 |
| 2009 | 0 | — | 0 | 210 |
| 2010 | 0 | — | 1 | 58 |
| 2011 | 0 | — | 0 | 70 |
| 2012 | 1 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 1 | 193 |
| 2016 | 0 | — | 0 | 213 |
| 2017 | 1 | — | 0 | 234 |
| 2018 | 0 | — | 3 | 262 |
| 2019 | 0 | — | 0 | 632 |
| 2020 | 0 | — | 0 | 248 |
| 2021 | 0 | — | 4 | 142 |
| 2022 | 1 | — | 0 | 202 |
| 2023 | 0 | — | 0 | 184 |
| 2024 | 0 | — | 0 | 112 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950680: Infant Heel Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950680
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026