510(k) · Cleared
ClearedDrager Incubator 8000 IC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager, Inc. · FMZ Incubator, Neonatal
Cleared on Apr 25, 1997 after a 597-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 of the 12 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Apr 25, 1997
- Review
- 597 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly. 5 of the 12 devices in this family, counting this one, have a Class I recall.
- This deviceK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK071175 Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007
- Descendant · cites it directly · 5 of its ownK020547 Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002 · Recalled
- Descendant · 2 generations on · 4 of its ownK072512 Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda…Datex-Ohmeda, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK152814 Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Recalled (Class I)
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · cites it directly6descendants
- K071175Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007 · 2 generations on5descendants
- K020547Ohmeda Medical Giraffe IncubatorOhmeda Medical · 2002 · cites it directly5descendants
- K072512Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible…Datex-Ohmeda, Inc. · 2007 · 2 generations on4descendants
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| +1 | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | Class I |
| +2 | K071175 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | 2007 | — |
| +1 | K020547 | Ohmeda Medical Giraffe Incubator | Ohmeda Medical | 2002 | 4 |
| +2 | K072512 | Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda… | Datex-Ohmeda, Inc. | 2007 | — |
| +2 | K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 1 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2022 | 2 | 2 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020543 (Ohmeda Medical, 2002) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/K954204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954204: Drager Incubator 8000 IC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954204
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026