510(k) · Cleared
ClearedInfant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Mar 18, 2016 as substantially equivalent to K150627 (Rapid Aid Corp., 2015) and 1 other predicate after a 255-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Mar 18, 2016
- Review
- 255 days
- Class
- Class I
- Product code
- MPO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K950680 (1995). 8 ancestors in all, the oldest K912715 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK950680 Infant Heel WarmerBaxter Healthcare Corp · 1995
- 4 generations backK961154 Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996 · Recalled
- 3 generations backK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- 2 generations backK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- 1 generation backK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- This deviceK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
Most influential descendants
Showing 1 of 1 · See all- K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950680 | Infant Heel Warmer | Baxter Healthcare Corp | 1995 | — |
| −4 | K961154 | Baxter Sodium Acetate Infant Heel Warmer | Baxter Healthcare Corp | 1996 | 1 |
| −3 | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| −2 | K040856 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid, Ltd. | 2004 | — |
| −1 | K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | 2015 | — |
| 0 (this device) | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| +1 | 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 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K150627 | Rapid Aid Instant Disposable Infant Heel WarmerSummary page 4…CooperSurgical Infant Heel Warmer is substantially equivalent to the following predicates: Primary Predicate: Rapid Aid Instant Disposable Infant Heel Warmer – Disc (K150627) Additional Predicate: DeRoyal Industries Infant Heel Warmer (K954716) Device Description The CooperSurgical Infant Heel Warmer… | 2015 |
| * | K954716 | Deroyal Industries Infant Heel WarmerSummary page 4…ollowing predicates: Primary Predicate: Rapid Aid Instant Disposable Infant Heel Warmer – Disc (K150627) Additional Predicate: DeRoyal Industries Infant Heel Warmer (K954716) Device Description The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer,… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | 2022 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K221154 (International Biomedical, 2022) has gone furthest, with 0 descendants of its own.
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. 2016, this device’s year, is highlighted.
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?
An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151845: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151845
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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