# K152809: Giraffe Incubator Carestation CS1

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Decided: Dec 31, 2015 after 94 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954204 (1997). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K101778: Giraffe Incubator, Ohmeda Medical (2010) Summary page 4.
- K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply), Datex-Ohmeda, Inc. (2007) Summary page 4.
- K020547: Ohmeda Medical Giraffe Incubator, Ohmeda Medical (2002) Summary page 4.
- K010222: Ohmeda Medical Giraffe Incubator, Ohmeda Medical (2001) Summary page 4.

## Most influential descendants
- 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
- 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
- Oct 11, 2019 · Class I · Z-0540-2020: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
- Sep 25, 2018 · Class II · Z-0480-2019: Potential electric leakage affecting the user.

## 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/K152809
Methodology: https://510kreport.com/methodology