# K102226: Dual Incu I

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Jan 4, 2011 after 148 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061856: V-2200 Infant Incubator, Atom Medical, Inc. (2006) Summary page 2.
- K071175: Ohmeda Medical Giraffe Omnibed, GE Healthcare (2007) Summary page 2.

## Recalls of this device
- May 1, 2012 · Class II · Z-1945-2012: There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
- Aug 23, 2011 · Not classified · Z-0340-2012: The caster with lock on the radiant-warming open type incubator may become loose or break.
- Aug 23, 2011 · Not classified · Z-0337-2012: The caster with lock on the incubator or infant warmer may become loose or break.
- Aug 23, 2011 · Not classified · Z-0339-2012: The caster with lock on the incubator may become loose or break.
- Aug 23, 2011 · Not classified · Z-0338-2012: The caster with lock on the incubator may become loose or break.

## Indications for use
The Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand. The Dual Incu i is an 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. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.

Source page: https://510kreport.com/device/K102226
Methodology: https://510kreport.com/methodology