# K053399: Versalet 7700 Care Center

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Infant Care, Inc.
- Decided: Aug 4, 2006 after 241 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
Longest line of descent: 4 generations back to K942948 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993051: Versalet 7700 Care Center, Model # 7700, Hill-Rom Air-Shields (2000) Summary page 1.
- K993407: Ohmeda Medical Omnibed, Ohmeda Medical (2000) Summary page 1.

## Indications for use
The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. This device is not intended for home use.

Source page: https://510kreport.com/device/K053399
Methodology: https://510kreport.com/methodology