510(k) · Cleared
ClearedPhoenix Infant Radiant Warmer, Model 100NWS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Hospital Supply Co. · FMT Warmer, Infant Radiant
Cleared on Dec 17, 2003 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 17, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMT? 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 FMT device
- #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMT
103in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMT
4in 2019
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · FMT
359in 2025
MAUDE reports naming product code FMT, 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 | 2 | — | 0 | 21 |
| 2008 | 0 | — | 1 | 114 |
| 2009 | 1 | — | 2 | 80 |
| 2010 | 1 | — | 0 | 106 |
| 2011 | 1 | — | 0 | 79 |
| 2012 | 4 | 103 | 0 | 54 |
| 2013 | 1 | — | 2 | 55 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 0 | — | 1 | 56 |
| 2016 | 0 | — | 1 | 56 |
| 2017 | 0 | — | 0 | 46 |
| 2018 | 1 | — | 4 | 79 |
| 2019 | 0 | — | 4 (4) | 1,437 |
| 2020 | 2 | — | 0 | 1,605 |
| 2021 | 1 | — | 0 | 473 |
| 2022 | 1 | — | 0 | 153 |
| 2023 | 1 | — | 0 | 175 |
| 2024 | 0 | — | 0 | 257 |
| 2025 | 1 | — | 0 | 359 |
| 2026 | 0 | — | 2 (2) | — |
What is it indicated for?
The PHOENIX Infant Radiant Warmer consists of an infrared heating element
placed over an infant in order to maintain the infant’s body temperature at a level
determined by the caregiver by means of radiant heat. It is designed to be used in
those areas of the health care facility that provide neonatal and infant care.
Federal law restricts this device to sale or use by or upon the order of a licensed
health care practitioner. Its use is restricted to health care facilities and only by
persons with specific training and experience in the use of the device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033040: Phoenix Infant Radiant Warmer, Model 100NWS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033040
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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