# K061856: V-2200 Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical, Inc.
- Decided: Sep 28, 2006 after 90 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 K962603 (1997). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021809: V-2100G Advanced Infant Incubator, Atom Medical Corp (2002) Summary page 1.
- K002355: Atom Infa Warmer V-505, Atom Medical Corp (2000) Summary page 1.
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 1.

## Most influential descendants
- K102710: Neo-Servo I (2010), 1 descendant of its own
- K132543: Infant Incubator (2014), 0 descendants of its own
- K102226: Dual Incu I (2011), 0 descendants of its own
- K102279: INCU I (2010), 0 descendants of its own

## 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. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This device is not intended as a transport incubator.

Source page: https://510kreport.com/device/K061856
Methodology: https://510kreport.com/methodology