510(k) · Cleared
Recalled · Class I · 2026Giraffe Omnibed Carestation CS1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex Ohmeda, Inc. · FMT Warmer, Infant Radiant
Cleared on Mar 2, 2022 as substantially equivalent to K152809 (Ohmeda Medical, A Division of Datex-Ohmeda, Inc., 2015) after a 114-day review. Its family tree reaches back 4 generations to 1997. 3 of the 10 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 5 times, including 2 Class I recalls.
- Decided
- Mar 2, 2022
- Review
- 114 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 5 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954204 (1997). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 3 generations backK020547 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002 · Recalled
- 2 generations backK072512 Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda…Datex-Ohmeda, Inc. · 2007
- 1 generation backK152809 Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · Recalled (Class I)
- This deviceK213551 Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260326 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation…Datex-Ohmeda, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −4 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −3 | K020547 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2002 | 4 |
| −2 | K072512 | Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda… | Datex-Ohmeda, Inc. | 2007 | — |
| −1 | K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015 | Class I |
| 0 (this device) | K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022 | — |
| +1 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +2 | K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K152809 | Giraffe Incubator Carestation CS1Summary page 4…Classification Names: Neonatal Incubator Regulation 21 CFR 880.5400 Neonatal Incubator Classification II Product Code: FMZ Predicate Device: Giraffe Incubator (K152809) Indications for Use: The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | 2025 | 1 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2026 | Class II | Z-2477-2026 | Component design/selection | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the… |
| May 1, 2026 | Class II | Z-2476-2026 | Component design/selection | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the… |
| Sep 3, 2024 | Class I | Z-0048-2025 | Use error | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors… |
| Jun 6, 2023 | Class I | Z-0140-2025 | Component design/selection | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were… |
| May 19, 2023 | Class II | Z-2100-2023 | Nonconforming Material/Component | GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation… |
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.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 4 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K251663 (Datex-Ohmeda, Inc., 2025) has gone furthest, with 1 descendant 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. 2022, 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?
The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed…
Read the full statement (138 words)
The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.
This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213551: Giraffe Omnibed Carestation CS1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213551
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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