510(k) · Cleared
ClearedInfant Heel Warmer by Intco
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Intco Medical Supply Co., Ltd. · MPO Infant Heel Warmer (Chemical Heat Pack)
Cleared on Sep 19, 2006 after a 302-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 19, 2006
- Review
- 302 days
- Class
- Class I
- Product code
- MPO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Rapid Aid Infant Heel Warmer Named without a submission number |
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.
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 Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis.
Note: The device is to be limited to use in hospitals, doctor's offices, and other healthcare facilities that administer health care services to newborns and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053254: Infant Heel Warmer by Intco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053254
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026