# K102710: Neo-Servo I

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Dec 22, 2010 after 93 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 K962603 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061856: V-2200 Infant Incubator, Atom Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K132543: Infant Incubator (2014), 0 descendants of its own

## Indications for use
The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. The incubator is provided with a function to control the infant's skin temperature. Environment of use - Hospitals, delivery suites, NICU

Source page: https://510kreport.com/device/K102710
Methodology: https://510kreport.com/methodology