# K991627: Wallaby 3 Phototherapy System, Model 3600

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: May 17, 1999 after 6 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: 1 generation back to K883779 (1988). 1 ancestor in all.
17 later devices descend from it; 2 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)
- K883779: Wallaby (TM) Blanket, Fiberoptic Medical Products, Inc. (1988) Summary page 1.

## 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
- K072097: Bilibee Led Phototherapy System, Model: 1 (2007), 3 descendants of its own

## Indications for use
The Wallaby 3 is intended to treat hyperbilirubinemia through phototherapy in a home or hospital environment.

Source page: https://510kreport.com/device/K991627
Methodology: https://510kreport.com/methodology