# K160745: neoBLUE compact LED Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: Dec 12, 2016 after 269 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103735: Mediled Mini, Medix I.C.S.A. (2011) Summary page 4.
- K083179: Mediled Phototherapy Lamp, Medix I.C.S.A. (2009) Summary page 4.

## Indications for use
The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.

Source page: https://510kreport.com/device/K160745
Methodology: https://510kreport.com/methodology