510(k) · Cleared
ClearedRW Resucitaire Infant Radiant Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air-Shields, Inc. · FMT Warmer, Infant Radiant
Cleared on May 3, 1995 after a 427-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- May 3, 1995
- Review
- 427 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK940951 RW Resucitaire Infant Radiant WarmerAir-Shields, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK060461 V-505 Infa WarmerAtom Medical, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK971366 IncuwarmerHill-Rom, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK993051 Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000
- Descendant · 2 generations on · 0 of its ownK103317 Resuscitation Unit 105Atom Medical Corporation · 2011
- Descendant · 2 generations on · 0 of its ownK102227 Infa Warmer IAtom Medical Corporation · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K060461V-505 Infa WarmerAtom Medical, Inc. · 2006 · cites it directly2descendants
- K971366IncuwarmerHill-Rom, Inc. · 1998 · cites it directly2descendants
- K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields · 2000 · cites it directly1descendant
- K103317Resuscitation Unit 105Atom Medical Corporation · 2011 · 2 generations on0descendants
- K102227Infa Warmer IAtom Medical Corporation · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940951 | RW Resucitaire Infant Radiant Warmer | Air-Shields, Inc. | 1995 | — |
| +1 | K060461 | V-505 Infa Warmer | Atom Medical, Inc. | 2006 | — |
| +1 | K971366 | Incuwarmer | Hill-Rom, Inc. | 1998 | — |
| +1 | K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | 2000 | — |
| +2 | K103317 | Resuscitation Unit 105 | Atom Medical Corporation | 2011 | — |
| +2 | K102227 | Infa Warmer I | Atom Medical Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 2 | 0 |
| 2011 | 2 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
5 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, K060461 (Atom Medical, Inc., 2006) has gone furthest, with 2 descendants of its own.
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) | — |
https://510kreport.com/device/K940951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940951: RW Resucitaire Infant Radiant Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940951
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026