# K243372: BiliWrap

- Pathway: 510(k) (Traditional)
- Applicant: Gerium Medical, Ltd.
- Decided: May 29, 2025 after 211 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: 4 generations back to K883779 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210289: Infant Phototherapy Equipment, Bistos Co., Ltd. (2021) Summary page 5.

## Indications for use
The BiliWrap Phototherapy System is intended for use to treat infants who have been diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The Phototherapy system can be used in a hospital or at home. The device is intended to be used in infants up to the age of 3 months, weighing less than 10 kg.

Source page: https://510kreport.com/device/K243372
Methodology: https://510kreport.com/methodology