# K182178: neoBLUE blanket LED Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated
- Decided: Dec 13, 2018 after 122 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 K940996 (1994). 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)
- K103589: Neoblue Blanket Led Phototherapy System, Natus Medical Incorporated (2011) Summary page 4.

## Indications for use
The neoBLUE blanket LED Phototherapy System is indicated for the treatment of unconjugated hyperbilirubinemia in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver. The neoBLUE blanket device provides intensive phototherapy underneath the patient and can be used with a bassinet, open bed, radiant warmer, incubator, or while holding the patient.

Source page: https://510kreport.com/device/K182178
Methodology: https://510kreport.com/methodology