# K003423: ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055

- Pathway: 510(k) (Traditional)
- Applicant: St. Francis Medical Equipment Co., Ltd.
- Decided: Feb 22, 2001 after 111 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K100234: HM-Lamp II (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K003423
Methodology: https://510kreport.com/methodology