# K974830: Ultra Bili Light

- Pathway: 510(k) (Traditional)
- Applicant: Physician Engineered Products, Inc.
- Decided: May 20, 1998 after 147 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190899: bili-hut (2019), 0 descendants of its own
- K110550: Bright Embrace Model SBL60 (2012), 0 descendants of its own

## Indications for use
The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treatment for Neonatal Hyperbilirubinemia.

Source page: https://510kreport.com/device/K974830
Methodology: https://510kreport.com/methodology