# K993712: Biliblanket Plus High Output Phototherapy System

- Pathway: 510(k) (Special)
- Applicant: Ohmeda Medical
- Decided: Nov 9, 1999 after 6 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmeda - BiliBlanket Plus (original): named in the summary without a submission number
- (no number) PEP - Ultra BiliLight: named in the summary without a submission number
- (no number) Medela - BiliBed: named in the summary without a submission number

## Most influential descendants
- K040068: Biliblanket Plus High Output Phototherapy System (2004), 0 descendants of its own

## Indications for use
The BiliBlanket Plus High Output Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period 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/K993712
Methodology: https://510kreport.com/methodology