# K213553: Giraffe Incubator Carestation CS1

- Pathway: 510(k) (Traditional)
- Applicant: Datex Ohmeda, Inc.
- Decided: Mar 2, 2022 after 114 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954204 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152814: Giraffe OmniBed Carestation CS1, Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company (2016) Summary page 4.

## Most influential descendants
- 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
- Jun 6, 2023 · Class I · Z-0141-2025: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease o

## Indications for use
The Giraffe Incubator Carestation 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/K213553
Methodology: https://510kreport.com/methodology