# K051869: Neoblue Cozy Led Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Oct 7, 2005 after 88 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: 2 generations back to K940996 (1994). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962612: Bilibed Phototherapy Lamp, Medela, Inc. (1996) Summary page 4.
- K022196: Natus Blue Light Phototherapy Unit, Natus Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K070180: Wallaby 4 (2007), 12 descendants of its own
- K072035: Resolve Uvb Phototherapy System (2007), 6 descendants of its own
- K170489: Skylit Phototherapy System (2017), 5 descendants of its own
- K173436: Luma Light System (2018), 3 descendants of its own
- K192642: 308nm Excimer System (2020), 2 descendants of its own

## Indications for use
The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.

Source page: https://510kreport.com/device/K051869
Methodology: https://510kreport.com/methodology