# K010222: Ohmeda Medical Giraffe Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Mar 21, 2001 after 56 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020547: Ohmeda Medical Giraffe Incubator (2002), 5 descendants of its own
- K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply) (2007), 4 descendants of its own
- K162821: Babyleo TN500 (2017), 3 descendants of its own
- K152809: Giraffe Incubator Carestation CS1 (2015), 3 descendants of its own
- K213551: Giraffe Omnibed Carestation CS1 (2022), 2 descendants of its own

## Recalls of this device
- Apr 28, 2020 · Class II · Z-2236-2020: 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
- Nov 18, 2016 · Class II · Z-1502-2017: 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 fi
- Apr 25, 2005 · Not classified · Z-1047-05: Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.

Source page: https://510kreport.com/device/K010222
Methodology: https://510kreport.com/methodology