510(k) · Cleared
Recalled · Class I · 2023Giraffe 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 Mar 2, 2022 as substantially equivalent to K152814 (Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company, 2016) after a 114-day review. Its family tree reaches back 4 generations to 1997. 4 of the 10 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 2, 2022
- Review
- 114 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954204 (1997). 7 ancestors in all. 2 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 · 4 generations backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- 3 generations backK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Recalled (Class I)
- 2 generations backK071175 Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007
- 1 generation backK152814 Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Recalled (Class I)
- This deviceK213553 Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · 2 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| −3 | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | Class I |
| −2 | 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 |
| 0 (this device) | K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022 | — |
| +1 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K152814 | Giraffe OmniBed Carestation CS1Summary page 4…es: Neonatal Incubator Regulation 21 CFR 880.5400 Neonatal Incubator Classification II Product Code: FMZ, FMT Predicate Device: Giraffe Omnibed Carestation CS1 (K152814) Indications for Use: The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | 2025 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2023 | Class I | Z-0141-2025 | 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… |
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.
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K101788Giraffe OmnibedOhmeda Medical · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 13 Class I recalls
- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- 4 of the 7 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K251663 (Datex-Ohmeda, Inc., 2025) has gone furthest, with 1 descendant 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. 2022, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213553: Giraffe Incubator 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/K213553
Report an extraction error
Are you the manufacturer?
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