# K061071: V-808 Atom Transcapsule

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical, Inc.
- Decided: Aug 29, 2006 after 134 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941106: Model TI500 Isolette Infant Incubator, Air-Shields, Inc. (1994) 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.

## Indications for use
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability. This device is not intended for home use.

Source page: https://510kreport.com/device/K061071
Methodology: https://510kreport.com/methodology