510(k) · Cleared
ClearedOhmeda Medical Giraffe Omnibed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · FMZ Incubator, Neonatal
Cleared on Jul 17, 2007 as substantially equivalent to K993407 (Ohmeda Medical, 2000) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1997. 3 of the 10 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 17, 2007
- Review
- 81 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954204 (1997). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 1 generation backK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Recalled (Class I)
- This deviceK071175 Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007
- Descendant · cites it directly · 3 of its ownK152814 Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK213553 Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK260326 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation…Datex-Ohmeda, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK102226 Dual Incu IAtom Medical Corporation · 2011 · Recalled
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · cites it directly3descendants
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on2descendants
- K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025 · 3 generations on1descendant
- K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026 · 4 generations on0descendants
- K102226Dual Incu IAtom Medical Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −1 | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | Class I |
| 0 (this device) | K071175 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | 2007 | — |
| +1 | K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016 | Class I |
| +2 | K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022 | Class I |
| +3 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +4 | K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2026 | — |
| +1 | K102226 | Dual Incu I | Atom Medical Corporation | 2011 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 1 |
| 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.
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 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? (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 |
|---|---|---|---|
| * | K993407 | Ohmeda Medical OmnibedSummary page 1…edicate Device Information Predicate Device 510(k) Number Ohmeda Medical Giraffe OmniBed K993407 Ohmeda Medical Giraffe OmniBed (with optional K020543 Servo Controlled Oxygen Delivery System) Intended Use St… | 2000 |
| * | K020543 | Ohmeda Medical Giraffe OmnibedSummary page 1…510(k) Number Ohmeda Medical Giraffe OmniBed K993407 Ohmeda Medical Giraffe OmniBed (with optional K020543 Servo Controlled Oxygen Delivery System) Intended Use Statement The OmniBed is a combination of an infant incubator and an inf… | 2002 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152814 (Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company, 2016) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K993407.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 OmniBed 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…
Read the full statement (136 words)
The OmniBed 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/K071175 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071175: Ohmeda Medical Giraffe Omnibed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071175
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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