# K993407: Ohmeda Medical Omnibed

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jan 5, 2000 after 89 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
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
6 of 14 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) Ohmeda - Ohio Care Plus Incubator (all models): named in the summary without a submission number
- (no number) Ohmeda - Ohio Infant Warmer System (all models): named in the summary without a submission number
- (no number) Ohmeda — Ohio Intensive Care Incubator: named in the summary without a submission number

## Most influential descendants
- K020543: Ohmeda Medical Giraffe Omnibed (2002), 6 descendants of its own
- K071175: Ohmeda Medical Giraffe Omnibed (2007), 5 descendants of its own
- K152814: Giraffe OmniBed Carestation CS1 (2016), 3 descendants of its own
- K070377: Giraffe and Panda Warmer (2007), 3 descendants of its own
- K213553: Giraffe Incubator Carestation CS1 (2022), 2 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
- Oct 5, 2018 · Class II · Z-0041-2020: GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the 
- Nov 18, 2016 · Class II · Z-1509-2017: 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.

## Indications for use
The OmniBed is a combination of an infant incubator (“incubator”) and an infant radiant warmer (“warmer”). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment.

Source page: https://510kreport.com/device/K993407
Methodology: https://510kreport.com/methodology