# K103589: Neoblue Blanket Led Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: May 13, 2011 after 157 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940996 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901987: Olympic Bili-Lite-Pad (TM), Olympic Medical Corp. (1990) Summary page 1.
- K051869: Neoblue Cozy Led Phototherapy System, Natus Medical, Inc. (2005) Summary page 1.
- K053568: Bilisoft Phototherapy System, Lumitex, Inc. (2006) Summary page 1.

## Most influential descendants
- K182178: neoBLUE blanket LED Phototherapy System (2018), 0 descendants of its own
- K163526: Bilicocoon™ Phototherapy System (2017), 0 descendants of its own

## Recalls of this device
- Oct 28, 2016 · Class II · Z-0770-2017: neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection 
- Sep 16, 2016 · Class II · Z-0769-2017: The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent th
- Mar 16, 2015 · Class II · Z-1412-2015: neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve di

## Indications for use
The neoBLUE blanket LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia. It can be used in the clinical setting or in the home.

Source page: https://510kreport.com/device/K103589
Methodology: https://510kreport.com/methodology