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
Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · FMZ Incubator, Neonatal
Cleared on Mar 17, 2016 as substantially equivalent to K101788 (Ohmeda Medical, 2010) and 3 other predicates after a 171-day review. Its family tree reaches back 3 generations to 1997. 4 of the 10 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 8 times, including 3 Class I recalls.
- Decided
- Mar 17, 2016
- Review
- 171 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 8 (3 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K954204 (1997). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 2 generations backK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Recalled (Class I)
- 1 generation backK071175 Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007
- This deviceK152814 Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016
- Descendant · cites it directly · 2 of its ownK213553 Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · 3 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 3 of 3 · See all- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · cites it directly2descendants
- K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025 · 2 generations on1descendant
- K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −2 | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | Class I |
| −1 | K071175 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | 2007 | — |
| 0 (this device) | K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016 | — |
| +1 | K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022 | Class I |
| +2 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +3 | 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 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 1 |
| 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.
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 FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K101788 | Giraffe OmnibedSummary page 4…sification Names: Incubator, Neonatal: (880.5400) Regulatory Class II Product Code: FMZ, FMT Predicate Device(s): Giraffe OmniBed, K101788, K071175 K020543, K993407 Device Description: The Giraffe OmniBed Carestation is an updated version of the cleared… | 2010 |
| * | K071175 | Ohmeda Medical Giraffe OmnibedSummary page 4…n Names: Incubator, Neonatal: (880.5400) Regulatory Class II Product Code: FMZ, FMT Predicate Device(s): Giraffe OmniBed, K101788, K071175 K020543, K993407 Device Description: The Giraffe OmniBed Carestation is an updated version of the cleared… | 2007 |
| * | K020543 | Ohmeda Medical Giraffe OmnibedSummary page 4…Incubator, Neonatal: (880.5400) Regulatory Class II Product Code: FMZ, FMT Predicate Device(s): Giraffe OmniBed, K101788, K071175 K020543, K993407 Device Description: The Giraffe OmniBed Carestation is an updated version of the cleared… | 2002 |
| * | K993407 | Ohmeda Medical OmnibedSummary page 4…r, Neonatal: (880.5400) Regulatory Class II Product Code: FMZ, FMT Predicate Device(s): Giraffe OmniBed, K101788, K071175 K020543, K993407 Device Description: The Giraffe OmniBed Carestation is an updated version of the cleared… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213553 | Giraffe Incubator Carestation CS1 Class I | 2022 | 2 |
Has anything in its family been recalled? (4 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… |
| Oct 11, 2019 | Class I | Z-0539-2020 | Device Design | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall. |
| Jul 26, 2019 | Class II | Z-0281-2020 | Nonconforming Material/Component | Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. |
| Sep 25, 2018 | Class II | Z-0479-2019 | Process design | Potential electric leakage affecting the user. |
The 5 latest of 8 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.
- K101788Giraffe OmnibedOhmeda Medical · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 13 Class I recalls
- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K213553 (Datex Ohmeda, Inc., 2022) has gone furthest, with 2 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. 2016, 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 (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 as stated in the FDA summary.
https://510kreport.com/device/K152814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152814: 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/K152814
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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