# K071828: Lullaby

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Clinical Systems
- Decided: Aug 6, 2007 after 34 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 K040853 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040853: Phoenix Phototherapy Unit CFL, Model 101, International Hospital Supply Co. (2004) Summary page 1.

## Most influential descendants
- K120168: Lullaby Led Phottherapy System (2012), 0 descendants of its own

## Indications for use
The Lullaby TM Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. This device is intended for professional use only by trained clinicians.

Source page: https://510kreport.com/device/K071828
Methodology: https://510kreport.com/methodology