# K190899: bili-hut

- Pathway: 510(k) (Traditional)
- Applicant: Little Sparrows Technologies, Inc.
- Decided: Sep 5, 2019 after 150 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 K974830 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974830: Ultra Bili Light, Physician Engineered Products, Inc. (1998) Summary page 4.

## Indications for use
The bili-hut™ provides phototherapy for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the clinical or home setting.

Source page: https://510kreport.com/device/K190899
Methodology: https://510kreport.com/methodology