510(k) · Cleared
ClearedInfant Heel WarmerTM; Heel Snuggler®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Oct 7, 2022 as substantially equivalent to K151845 (CooperSurgical, Inc., 2016) after a 169-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Oct 7, 2022
- Review
- 169 days
- Class
- Class I
- Product code
- MPO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950680 (1995). 9 ancestors in all, the oldest K912715 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK950680 Infant Heel WarmerBaxter Healthcare Corp · 1995
- 5 generations backK961154 Baxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp · 1996 · Recalled
- 4 generations backK032989 Medi-Heat Infant Heel WarmerMediheat, Inc. · 2003
- 3 generations backK040856 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid, Ltd. · 2004
- 2 generations backK150627 Rapid Aid Instant Disposable Infant Heel WarmerRapid Aid Corp. · 2015
- 1 generation backK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- This deviceK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950680 | Infant Heel Warmer | Baxter Healthcare Corp | 1995 | — |
| −5 | K961154 | Baxter Sodium Acetate Infant Heel Warmer | Baxter Healthcare Corp | 1996 | 1 |
| −4 | K032989 | Medi-Heat Infant Heel Warmer | Mediheat, Inc. | 2003 | — |
| −3 | 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 | — |
| −1 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)Summary page 4…510(k) number: K221154 Predicate Device: CooperSurgical Inc. – Infant Heel Warmer (Model 24401), WarmGel® Infant Heel Warmer (Model 20418)– K151845 Reference Device: Omni Therm Inc.– Omni Warm Gel Packs – K936084 Device Description: The Infant Heel Warm… | 2016 |
| † | K936084 | Omni Warm Gel Packs | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
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. 2022, 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?
The Infant Heel Warmer™,; Heel Snuggler® are instant warm packs 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, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™; Heel Snuggler® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant’s heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor’s offices, and other healthcare settings.
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/K221154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221154: Infant Heel WarmerTM; Heel Snuggler®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221154
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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