510(k) · Cleared
ClearedMedi-Heat Infant Heel Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediheat, Inc. · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Oct 22, 2003 as substantially equivalent to K912715 (Prism Technologies, Inc., 1991) and 2 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 28 days
- Class
- Class I
- Product code
- MPO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K950680 (1995). 4 ancestors in all, the oldest K912715 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950680 Infant Heel WarmerBaxter Healthcare Corp · 1995
- 1 generation backK961154 Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996 · Recalled
- This deviceK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- Descendant · 3 generations on · 1 of its ownK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
Most influential descendants
Showing 4 of 4 · See all- K040856Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004 · cites it directly3descendants
- K150627Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015 · 2 generations on2descendants
- K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc. · 2016 · 3 generations on1descendant
- K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950680 | Infant Heel Warmer | Baxter Healthcare Corp | 1995 | — |
| −1 | K961154 | Baxter Sodium Acetate Infant Heel Warmer | Baxter Healthcare Corp | 1996 | 1 |
| 0 (this device) | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| +1 | K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid, Ltd. | 2004 | — |
| +2 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015 | — |
| +3 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| +4 | K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K912715 | Instant Warm Gel PackSummary page 1…[807.92(a)(3)] Device Name 510(k) Number Instant Warm Gel Pack by Prism K912715 Omni Warm Gel Pack K936084 I Baxter Sodium Acetate Infant Heel Warm… | 1991 |
| * | K936084 | Omni Warm Gel PacksSummary page 1…e Name 510(k) Number Instant Warm Gel Pack by Prism K912715 Omni Warm Gel Pack K936084 I Baxter Sodium Acetate Infant Heel Warmer K961154 I I--- - ~~… | 1994 |
| * | K961154 | Baxter Sodium Acetate Infant Heel WarmerSummary page 1…k by Prism K912715 Omni Warm Gel Pack K936084 I Baxter Sodium Acetate Infant Heel Warmer K961154 I I--- - ~~ _ _ DeRoyal Infant Heel Warmer… | 1996 |
| * | — | DeRoyal Infant Heel Warmer Named without a submission number | |
| * | — | Tempra Heat Pack Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | 2004 | 3 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K040856 (Rapid Aid, Ltd., 2004) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K912715.
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?
MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032989: Medi-Heat 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/K032989
Report an extraction error
Are you the manufacturer?
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