# K922836: Chromophare

- Pathway: 510(k) (Traditional)
- Applicant: Berchtold Holding GmbH
- Decided: Oct 9, 1992 after 119 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031068: Stryker Visum Surgical Lighting System (2003), 3 descendants of its own
- K982063: Alm Prismalix (PRX) Surgical Light (1998), 2 descendants of its own
- K060802: Visum Led Surgical Lighting System (2006), 1 descendant of its own
- K132551: ZF 720 (2014), 0 descendants of its own
- K132747: Visum Blade Led Surgical Lighting System (2013), 0 descendants of its own

## Recalls of this device
- Nov 16, 2009 · Not classified · Z-0591-2011: A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop.

Source page: https://510kreport.com/device/K922836
Methodology: https://510kreport.com/methodology