# K101778: Giraffe Incubator

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical
- Decided: Jul 21, 2010 after 26 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Giraffe Incubator: named in the summary without a submission number

## 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

## 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
- Jan 8, 2013 · Class I · Z-1051-2013: Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.

## Indications for use
The Giraffe Incubator is an Infant Incubator. Incubators provide heat 6na 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/K101778
Methodology: https://510kreport.com/methodology