# K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply)

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Oct 3, 2007 after 27 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.
4 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020547: Ohmeda Medical Giraffe Incubator, Ohmeda Medical (2002) Summary page 1.

## Most influential descendants
- K152809: Giraffe Incubator Carestation CS1 (2015), 3 descendants of its own
- K213551: Giraffe Omnibed 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

## Indications for use
The Giraffe Incubator 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%)

Source page: https://510kreport.com/device/K072512
Methodology: https://510kreport.com/methodology