# K093618: Bili-Mirror Model BLM-1

- Pathway: 510(k) (Traditional)
- Applicant: Physician Engineered Products, Inc.
- Decided: Apr 23, 2010 after 151 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: 1 generation back to K043234 (2005). 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)
- K043234: Light Drape, Wrapped IN Comfort (2005) Summary page 1.

## Indications for use
Bill-Mirrors are intended to attach to overhead phototherapy light fixtures to limit the scattering of light.

Source page: https://510kreport.com/device/K093618
Methodology: https://510kreport.com/methodology