# K851449: Ohmeda 5000 Infant Warmer System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jun 7, 1985 after 57 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- May 5, 2017 · Class II · Z-2323-2017: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could f

Source page: https://510kreport.com/device/K851449
Methodology: https://510kreport.com/methodology