# K904965: Shampaine 1000 Series Angenieux AX-14 Duo,AX-4

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Equipment Group
- Decided: Jan 16, 1991 after 72 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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
- K040735: Alm X'ten (X10) Surgical Light System (2004), 15 descendants of its own
- K070442: Powerled Surgical Light System (2007), 14 descendants of its own
- K072072: Harmony Led-1 Surgical Lighting System (2007), 10 descendants of its own
- K093009: Mach Led SC (2010), 4 descendants of its own
- K113679: Lucea Led Surgical Light System (2012), 2 descendants of its own

Source page: https://510kreport.com/device/K904965
Methodology: https://510kreport.com/methodology