510(k) · Cleared
ClearedDeroyal Industries Infant Heel Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Debusk Knitting Mills, Div. Deroyal Industries · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Jan 11, 1996 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 11, 1996
- Review
- 90 days
- Class
- Class I
- Product code
- MPO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK954716 Deroyal Industries Infant Heel WarmerDebusk Knitting Mills, Div. Deroyal Industries · 1996
- Descendant · cites it directly · 1 of its ownK151845 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer…CooperSurgical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK221154 Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022
- Descendant · cites it directly · 0 of its ownK040044 Heel Snuggler, Model 99047Respironics, Inc. · 2004 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc. · 2016 · cites it directly1descendant
- K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical · 2022 · 2 generations on0descendants
- K040044Heel Snuggler, Model 99047Respironics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954716 | Deroyal Industries Infant Heel Warmer | Debusk Knitting Mills, Div. Deroyal Industries | 1996 | — |
| +1 | K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) | CooperSurgical, Inc. | 2016 | — |
| +2 | K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | 2022 | — |
| +1 | K040044 | Heel Snuggler, Model 99047 | Respironics, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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, K151845 (CooperSurgical, Inc., 2016) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K954716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954716: Deroyal Industries 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/K954716
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026