510(k) · Cleared
Recalled · Class I · 2026Panda iRes Warmer, Giraffe Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · FMT Warmer, Infant Radiant
Cleared on Feb 12, 2021 as substantially equivalent to K122267 (Ohmeda Medical, A Division of Datex-Ohmeda, Inc., 2012) after a 241-day review. Its family tree reaches back 2 generations to 2010. 3 of the 3 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including a Class I recall.
- Decided
- Feb 12, 2021
- Review
- 241 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 3 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101804 (2010). No later device cites it as a predicate yet. 3 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK101804 Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010 · Recalled (Class I)
- 1 generation backK122267 Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2012 · Recalled (Class I)
- This deviceK201628 Panda iRes Warmer, Giraffe WarmerGE Healthcare · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101804 | Giraffe and Panda Warmers | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010 | Class I |
| −1 | K122267 | Giraffe and Panda Warmers | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012 | Class I |
| 0 (this device) | K201628 | Panda iRes Warmer, Giraffe Warmer | GE Healthcare | 2021 | — |
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.
3 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 |
|---|---|---|---|
| * | K122267 | Giraffe and Panda WarmersSummary page 4…21 CFR 880.5130 Infant radiant warmer. Classification II Product Code: FMT Predicate Device: Panda Warmer, Giraffe Warmer (K122267) R-81 Indications for U… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2026 | Class I | Z-2358-2026 | Process control | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or… |
| Aug 9, 2024 | Class II | Z-3080-2024 | Process control | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design.… |
| Aug 9, 2024 | Class II | Z-3081-2024 | Process control | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design.… |
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.
- K122267Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K101804Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K122267.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 thermoregulate 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 (Sp02) and…
Read the full statement (114 words)
Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate 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 (Sp02) 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/K201628 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201628: Panda iRes Warmer, Giraffe Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201628
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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