# K061280: V-2200 Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Jun 27, 2006 after 50 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: 1 generation back to K001242 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001242: Isolette Infant Incubator, Model C2HS, Hill-Rom Air-Shields (2000) Summary page 1.
- K021809: V-2100G Advanced Infant Incubator, Atom Medical Corp (2002) Summary page 1.

## Indications for use
The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. 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. This device is not intended as a transport incubator.

Source page: https://510kreport.com/device/K061280
Methodology: https://510kreport.com/methodology