# K993051: Versalet 7700 Care Center, Model # 7700

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Air-Shields
- Decided: Feb 3, 2000 after 143 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: 3 generations back to K942948 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940951: RW Resucitaire Infant Radiant Warmer, Air-Shields, Inc. (1995) Summary page 1.
- K960980: Isolette Infant Incubator, Air-Shields, Inc. (1996) Summary page 1.
- K971366: Incuwarmer, Hill-Rom, Inc. (1998) Summary page 1.
- K971198: Babytherm 8004 Babytherm 8010, Drager, Inc. (1997) Summary page 1.

## Most influential descendants
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own

## 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 and convective heat. Accessories and options to the device permit environmental control and monitoring including humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

Source page: https://510kreport.com/device/K993051
Methodology: https://510kreport.com/methodology