510(k) · Cleared
Recalled · Class II · 2020Ohmeda Medical Giraffe Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMZ Incubator, Neonatal
Cleared on May 9, 2002 as substantially equivalent to K010222 (Ohmeda Medical, 2001) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1997. 2 of the 9 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- May 9, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954204 (1997). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- This deviceK020547 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002
- Descendant · cites it directly · 4 of its ownK072512 Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda…Datex-Ohmeda, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK152809 Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK213551 Giraffe Omnibed 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
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K072512Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible…Datex-Ohmeda, Inc. · 2007 · cites it directly4descendants
- K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · cites it directly3descendants
- K213551Giraffe Omnibed 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| 0 (this device) | K020547 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2002 | — |
| +1 | 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 |
| +2 | K213551 | Giraffe Omnibed 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K010222 | Ohmeda Medical Giraffe IncubatorSummary page 1…nformation The Giraffe Incubator is substantially equivalent to the following Class II devices: Device Last 510(k) , Number Ohmeda Medical Giraffe Incubator (original) K010222 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe In… | 2001 |
| * | K954204 | Drager Incubator 8000 ICSummary page 1…is substantially equivalent to the following Class II devices: Device Last 510(k) , Number Ohmeda Medical Giraffe Incubator (original) K010222 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe Incubator is an infant bed which pr… | 1997 |
| * | K001242 | Isolette Infant Incubator, Model C2HSSummary page 1…Class II devices: Device Last 510(k) , Number Ohmeda Medical Giraffe Incubator (original) K010222 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe Incubator is an infant bed which provides thermal support for infants who are un… | 2000 |
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? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2020 | Class II | Z-2236-2020 | Device Design | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed. |
| Nov 18, 2016 | Class II | Z-1505-2017 | Under Investigation by firm | Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where… |
| Apr 25, 2005 | Not classified | Z-1047-05 | Other | Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply. |
| Jun 13, 2003 | Not classified | Z-1064-03 | Other | Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems. |
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.
- K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Incubator 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 for 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020547: Ohmeda Medical Giraffe Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020547
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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