# K172656: BiliLux

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: May 1, 2018 after 238 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: 3 generations back to K940996 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113206: Nanoblutm 500, Draeger Medical Systems, Inc. (2012) Summary page 4.

## Indications for use
The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

Source page: https://510kreport.com/device/K172656
Methodology: https://510kreport.com/methodology