# K943360: Ohio Care Plus Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Sep 29, 1994 after 79 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has 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.

## Most influential descendants
- K971366: Incuwarmer (1998), 2 descendants of its own
- K993051: Versalet 7700 Care Center, Model # 7700 (2000), 1 descendant of its own
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own

## Recalls of this device
- Dec 26, 2023 · Class I · Z-0957-2024: GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be uprigh

Source page: https://510kreport.com/device/K943360
Methodology: https://510kreport.com/methodology