# K984589: Phototherapy Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Apr 20, 1999 after 117 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K072097: Bilibee Led Phototherapy System, Model: 1 (2007), 3 descendants of its own
- K210289: Infant Phototherapy Equipment (2021), 2 descendants of its own
- K251308: SnugLit (TM) Wearable Phototherapy System (SNGL-01-US) (2026), 0 descendants of its own
- K243372: BiliWrap (2025), 0 descendants of its own

## Indications for use
Medela’s phototherapy lamp is intended for the treatment of excessive serum-bilirubin concentrations in newbotn babies.

Source page: https://510kreport.com/device/K984589
Methodology: https://510kreport.com/methodology