510(k) · Cleared
ClearedGiraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · FMZ Incubator, Neonatal
Cleared on Oct 22, 2025 as substantially equivalent to K213551 (Datex Ohmeda, Inc., 2022) and 1 other predicate after a 145-day review. Its family tree reaches back 5 generations to 1997. 7 of the 16 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 22, 2025
- Review
- 145 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954204 (1997). 14 ancestors in all. 1 later device descends from it, 1 citing it directly. 7 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 4 generations backK020547 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002 · Recalled
- 3 generations backK072512 Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda…Datex-Ohmeda, Inc. · 2007
- 2 generations backK152809 Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · Recalled (Class I)
- 1 generation backK213551 Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 2022 · Recalled (Class I)
- This deviceK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · cites it directly · 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 1 of 1 · See all- K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −4 | K020547 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2002 | 4 |
| −3 | K072512 | Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda… | Datex-Ohmeda, Inc. | 2007 | — |
| −2 | K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015 | Class I |
| −1 | K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022 | Class I |
| 0 (this device) | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +1 | 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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 1 |
| 2007 | 1 | 0 |
| 2010 | 2 | 2 |
| 2016 | 1 | 1 |
| 2022 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
7 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 FMZ device
- #1 K260326 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™…score 13.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K213551 | Giraffe Omnibed Carestation CS1Summary page 5…Regulation Names: Neonatal Incubator Regulation Number: 21 CFR 880.5400 Classification: Class II Product Codes: FMZ, FMT Predicate Devices: K213551 - Giraffe OmniBed Carestation (CS1) K213553 - Giraffe Incubator Carestation (CS1) Predicate Device D… | 2022 |
| * | K213553 | Giraffe Incubator Carestation CS1Summary page 5…CFR 880.5400 Classification: Class II Product Codes: FMZ, FMT Predicate Devices: K213551 - Giraffe OmniBed Carestation (CS1) K213553 - Giraffe Incubator Carestation (CS1) Predicate Device Datex-Ohmeda, Inc. Manufacturer: 9900 Innovation Drive… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | 2026 | 0 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
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.
- K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 2022 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Direct predicate · ◆ in the 2022 ancestors bar of FIG. 11 Class I recall
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · 2 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101778Giraffe IncubatorOhmeda Medical · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K101788Giraffe OmnibedOhmeda Medical · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 13 Class I recalls
- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 10 of the 14 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K260326 (Datex-Ohmeda, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, 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 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
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 (209 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% ).
The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature-controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K251663: Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K251663
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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