# K131196: Infant Phototherapy Bilitron Sky 5006

- Pathway: 510(k) (Traditional)
- Applicant: Fanem Lda
- Decided: Feb 20, 2014 after 300 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 1.

## Indications for use
The Fanem Infant Phototherapy Bilitron Sky 5006 is intended to treat neonatal hyperbilirubinemia by providing phototherapeutic light to the body of the patient. It is intended for use on the recommendation and under the supervision of healthcare professionals.

Source page: https://510kreport.com/device/K131196
Methodology: https://510kreport.com/methodology