510(k) · Cleared
Recalled · Class II · 2020Ohmeda Medical Omnibed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMZ Incubator, Neonatal
Cleared on Jan 5, 2000 after an 89-day review. The FDA summary names its predicate without a number. 6 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 5, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 4
- Predicates
- 0
13 later devices descend from it, 6 citing it directly. 6 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK993407 Ohmeda Medical OmnibedOhmeda Medical · 2000
- Descendant · cites it directly · 6 of its ownK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK071175 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 · cites it directly · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK213553 Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K020543Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002 · cites it directly6descendants
- K071175Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007 · cites it directly5descendants
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · cites it directly3descendants
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · cites it directly3descendants
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993407 | Ohmeda Medical Omnibed | Ohmeda Medical | 2000 | — |
| +1 | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | Class I |
| +1 | 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 |
| +1 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| +2 | K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2006 | 1 | 0 |
| 2007 | 3 | 1 |
| 2009 | 1 | 1 |
| 2011 | 1 | 0 |
| 2013 | 1 | 1 |
| 2016 | 1 | 1 |
| 2019 | 1 | 0 |
| 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.
6 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 |
|---|---|---|---|
| * | — | Ohmeda - Ohio Care Plus Incubator (all models) Named without a submission number | |
| * | — | Ohmeda - Ohio Infant Warmer System (all models) Named without a submission number | |
| * | — | Ohmeda — Ohio Intensive Care Incubator Named without a submission number |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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. |
| Oct 5, 2018 | Class II | Z-0041-2020 | Labeling design | GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source… |
| Nov 18, 2016 | Class II | Z-1509-2017 | 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. |
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.
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- 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 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
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 | — |
What is it indicated for?
The OmniBed is a combination of an infant incubator (“incubator”) and an infant radiant warmer (“warmer”). 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.
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/K993407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993407: Ohmeda Medical Omnibed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993407
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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