# K021809: V-2100G Advanced Infant Incubator

- Pathway: 510(k) (Abbreviated)
- Applicant: Atom Medical Corp
- Decided: Jul 18, 2002 after 45 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Air Shields Isolette Infant Incubators and Accessories: named in the summary without a submission number
- (no number) Ohmeda Ohio Care Plus Infant Incubators and Accessories: named in the summary without a submission number

## Most influential descendants
- K061856: V-2200 Infant Incubator (2006), 4 descendants of its own
- 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-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.

Source page: https://510kreport.com/device/K021809
Methodology: https://510kreport.com/methodology