# K040068: Biliblanket Plus High Output Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Apr 16, 2004 after 93 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- 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 K993712 (1999). 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)
- K993712: Biliblanket Plus High Output Phototherapy System, Ohmeda Medical (1999) Summary page 1.

## Indications for use
The BiliBlanket Plus High Output (67.5 µW/cm²/nm maximum) Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, in the hospital or home setting. In addition, the device has an optional fiberoptic cable attachment for use in transillumination of the neonate.

Source page: https://510kreport.com/device/K040068
Methodology: https://510kreport.com/methodology