# K071175: Ohmeda Medical Giraffe Omnibed

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Jul 17, 2007 after 81 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954204 (1997). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993407: Ohmeda Medical Omnibed, Ohmeda Medical (2000) Summary page 1.
- K020543: Ohmeda Medical Giraffe Omnibed, Ohmeda Medical (2002) Summary page 1.

## Most influential descendants
- K152814: Giraffe OmniBed Carestation CS1 (2016), 3 descendants of its own
- K213553: Giraffe Incubator Carestation CS1 (2022), 2 descendants of its own
- K251663: Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (2025), 1 descendant of its own
- K260326: Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (2026), 0 descendants of its own
- K102226: Dual Incu I (2011), 0 descendants of its own

## Indications for use
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. 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. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Source page: https://510kreport.com/device/K071175
Methodology: https://510kreport.com/methodology