# K020547: Ohmeda Medical Giraffe Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: May 9, 2002 after 79 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954204 (1997). 3 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K010222: Ohmeda Medical Giraffe Incubator, Ohmeda Medical (2001) Summary page 1.
- K954204: Drager Incubator 8000 IC, Drager, Inc. (1997) Summary page 1.
- K001242: Isolette Infant Incubator, Model C2HS, Hill-Rom Air-Shields (2000) Summary page 1.

## Most influential descendants
- K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply) (2007), 4 descendants of its own
- 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
- Nov 18, 2016 · Class II · Z-1505-2017: Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fi
- Apr 25, 2005 · Not classified · Z-1047-05: Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
- Jun 13, 2003 · Not classified · Z-1064-03: Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

## 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 for 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/K020547
Methodology: https://510kreport.com/methodology