510(k) · Cleared
Recalled · 2009Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Air-Shields · FMT Warmer, Infant Radiant
Cleared on Nov 17, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled once.
- Decided
- Nov 17, 2000
- Review
- 23 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 1
- Predicates
- 0
18 later devices descend from it, 6 citing it directly. 6 of the 19 devices in this family, counting this one, have a Class I recall.
- This deviceK003335 Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer…Hill-Rom Air-Shields · 2000
- Descendant · cites it directly · 10 of its ownK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK070247 Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK120642 Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK072157 Modification to Giraffe and Panda Warmers (Giraffe and Panda…Ohmeda Medical · 2007 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · cites it directly10descendants
- K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · cites it directly4descendants
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on3descendants
- K120642Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012 · cites it directly2descendants
- K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical · 2007 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair… | Hill-Rom Air-Shields | 2000 | — |
| +1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| +1 | K070247 | Giraffe and Panda Bag and Mask Resuscitation System | Ohmeda Medical | 2007 | Class I |
| +2 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| +1 | K120642 | Resuscitaire with Autobreath | Draeger Medical Systems, Inc. | 2012 | 1 |
| +3 | K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible… | Ohmeda Medical | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2007 | 4 | 3 |
| 2009 | 1 | 1 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
6 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070210 | Giraffe and Panda T- Piece Resuscitation System Class I | 2007 | 10 |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation System Class I | 2007 | 4 |
| K120642 | Resuscitaire with Autobreath | 2012 | 2 |
| K120937 | Sunflower Warner | 2012 | 0 |
| K020966 | Rpi Replacement Heating Elements | 2002 | 0 |
| K021531 | Rpi Replacement Phototherapy Lights | 2002 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2009 | Not classified | Z-1693-2009 | Process control | Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K070210 (Ohmeda Medical, 2007) has gone furthest, with 10 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/K003335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003335
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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