# K103828: Bili-Therapy Spot Type

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Mar 29, 2011 after 91 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- 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 K940996 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070180: Wallaby 4, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Most influential descendants
- K160238: Airborne Phototherapy Light (2016), 0 descendants of its own
- K142332: BT-400 (2015), 0 descendants of its own

## Indications for use
The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.

Source page: https://510kreport.com/device/K103828
Methodology: https://510kreport.com/methodology