# K070180: Wallaby 4

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: May 18, 2007 after 119 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). 6 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991627: Wallaby 3 Phototherapy System, Model 3600, Respironics, Inc. (1999) Summary page 1.
- K051869: Neoblue Cozy Led Phototherapy System, Natus Medical, Inc. (2005) Summary page 1.
- K022196: Natus Blue Light Phototherapy Unit, Natus Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K103828: Bili-Therapy Spot Type (2011), 2 descendants of its own

## Indications for use
The Bili-Tx is intended to treat hyperbilirubinemia through phototherapy in a home or hospital/institutional environment.

Source page: https://510kreport.com/device/K070180
Methodology: https://510kreport.com/methodology