# K142332: BT-400

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA
- Decided: Mar 20, 2015 after 212 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: 5 generations back to K940996 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103828: Bili-Therapy Spot Type, Atom Medical Corporation (2011) Summary page 4.

## Indications for use
BT-400 is the Phototherapy unit intended for the treatment of Neonatal Hyperbilirubinemia caused by Indirect Hyperbilirubinemia.

Source page: https://510kreport.com/device/K142332
Methodology: https://510kreport.com/methodology