510(k) · Cleared
Recalled · Class I · 2018Giraffe and Panda Warmers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · FMT Warmer, Infant Radiant
Cleared on Oct 2, 2012 as substantially equivalent to K101804 (Ohmeda Medical, A Division of Datex-Ohmeda, Inc., 2010) after a 64-day review. Its family tree reaches back 1 generation to 2010. 4 of the 4 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 9 times, including a Class I recall.
- Decided
- Oct 2, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 9 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101804 (2010). 2 later devices descend from it, 2 citing it directly. 4 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK101804 Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010 · Recalled (Class I)
- This deviceK122267 Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK201628 Panda iRes Warmer, Giraffe WarmerGE Healthcare · 2021 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK123309 Giraffe and Panda WarmersOhmeda Medical · 2013 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101804 | Giraffe and Panda Warmers | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010 | Class I |
| 0 (this device) | K122267 | Giraffe and Panda Warmers | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012 | — |
| +1 | K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021 | Class I |
| +1 | K123309 | Giraffe and Panda Warmers | Ohmeda Medical | 2013 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 2021 | 1 | 1 |
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.
4 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? (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 |
|---|---|---|---|
| * | K101804 | Giraffe and Panda WarmersSummary page 1…lUsual Name: Infant Warmer Classification Names: Warmer, Infant Radiant Product Code: FMT 880.5130 Predicate Device (s): Giraffe and Panda Warmers; K 10 1804 DeviceDescription: The Giraffe and Panda Warmers are devices with a radiant… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2018 | Class II | Z-0482-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0481-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0483-2019 | Process design | Potential electric leakage affecting the user. |
| Sep 25, 2018 | Class II | Z-0484-2019 | Process design | Potential electric leakage affecting the user. |
| Apr 2, 2014 | Class II | Z-1547-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1550-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1549-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Apr 2, 2014 | Class II | Z-1548-2014 | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. |
| Oct 1, 2013 | Class I | Z-1072-2014 | Component design/selection | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
The 5 latest of 9 recalls; the web page lists all.
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.
- K101804Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and…
Read the full statement (114 words)
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122267: Giraffe and Panda Warmers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122267
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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