# K123937: Atom Transcapsule  V-707

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: May 23, 2013 after 154 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: 1 generation back to K941106 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. Environment of use - Hospitals, delivery suites, MCU, and transport

Source page: https://510kreport.com/device/K123937
Methodology: https://510kreport.com/methodology