# K111547: Bili-Therapy Pad Type

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Apr 12, 2012 after 314 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.
No later device cites it as a predicate yet.
0 of 8 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.

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

Source page: https://510kreport.com/device/K111547
Methodology: https://510kreport.com/methodology