# K954204: Drager Incubator 8000 IC

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Apr 25, 1997 after 597 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
5 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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
- K020547: Ohmeda Medical Giraffe Incubator (2002), 5 descendants of its own
- K072512: Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible Power Supply) (2007), 4 descendants of its own
- K152814: Giraffe OmniBed Carestation CS1 (2016), 3 descendants of its own

Source page: https://510kreport.com/device/K954204
Methodology: https://510kreport.com/methodology