# K031068: Stryker Visum Surgical Lighting System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 12, 2003 after 130 days
- Product code: FSY (Light, Surgical, Ceiling Mounted)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922836 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922836: Chromophare, Berchtold Holding GmbH (1992) Summary page 1.

## Most influential descendants
- 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 7, 2011 · Not classified · Z-0913-2012: Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly co
- Aug 23, 2011 · Not classified · Z-0137-2012: Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
- Apr 15, 2010 · Not classified · Z-1641-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1643-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1640-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1645-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1642-2010: Installation records are incomplete.
- Apr 15, 2010 · Not classified · Z-1644-2010: Installation records are incomplete.

## Indications for use
The intended use of the Stryker Visumm Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.

Source page: https://510kreport.com/device/K031068
Methodology: https://510kreport.com/methodology