# K022196: Natus Blue Light Phototherapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Sep 19, 2002 after 76 days
- Product code: LBI (Unit, Neonatal Phototherapy)
- Device class: 2
- Regulation: 21 CFR 880.5700
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940996 (1994). 1 ancestor in all.
29 later devices descend from it; 8 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940996: Olympic Bili-Lite, Olympic Medical Corp. (1994) Summary page 1.

## Most influential descendants
- K051869: Neoblue Cozy Led Phototherapy System (2005), 17 descendants of its own
- 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

## Recalls of this device
- Apr 3, 2017 · Class II · Z-1924-2017: The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which a
- Apr 11, 2016 · Class II · Z-2001-2016: The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
- Aug 5, 2015 · Class II · Z-0149-2016: The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information 
- Nov 19, 2014 · Class II · Z-0847-2015: Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity o
- Oct 1, 2009 · Not classified · Z-0420-2010: The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been

## Indications for use
The NatusO Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.

Source page: https://510kreport.com/device/K022196
Methodology: https://510kreport.com/methodology