510(k) · Cleared
Recalled · Class II · 2021Heel Snuggler, Model 99047
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Jan 27, 2004 as substantially equivalent to K954716 (Debusk Knitting Mills, Div. Deroyal Industries, 1996) after a 15-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- Jan 27, 2004
- Review
- 15 days
- Class
- Class I
- Product code
- MPO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954716 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954716 Deroyal Industries Infant Heel WarmerDebusk Knitting Mills, Div. Deroyal Industries · 1996
- This deviceK040044 Heel Snuggler, Model 99047Respironics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954716 | Deroyal Industries Infant Heel Warmer | Debusk Knitting Mills, Div. Deroyal Industries | 1996 | — |
| 0 (this device) | K040044 | Heel Snuggler, Model 99047 | Respironics, Inc. | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K954716 | Deroyal Industries Infant Heel WarmerSummary page 2…s traditional 510(k) submittal demonstrates that the Heel Snuggler is substantially equivalent to c, DeRoyal Industries, Inc. Infant Heel Warmer (K954716). Design verification tests were performed on the Heel Snuggler as a result of the risk analysis and t:l… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2021 | Class II | Z-0507-2022 | No Marketing Application | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K954716.
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?
The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040044: Heel Snuggler, Model 99047.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040044
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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