510(k) · Cleared
ClearedModification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply)
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 3, 2007 as substantially equivalent to K020547 (Ohmeda Medical, 2002) after a 27-day review. Its family tree reaches back 2 generations to 1997. 2 of the 9 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Oct 3, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954204 (1997). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 1 generation backK020547 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002 · Recalled
- This deviceK072512 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −1 | K020547 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2002 | 4 |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020547 | Ohmeda Medical Giraffe IncubatorSummary page 1…Giraffe Incubator Predicate Device Information Predicate Device 510(k) Number Giraffe Incubator K020547 Intended Use Statement The Giraffe Incubator is an Infant Incubator. Incubators provide heat in a controlled manner to neon… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152809 | Giraffe Incubator Carestation CS1 Class I | 2015 | 3 |
Has anything in its family been recalled? (2 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.
- 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K152809 (Ohmeda Medical, A Division of Datex-Ohmeda, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K020547.
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 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 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/K072512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072512
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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