# K132747: Visum Blade Led Surgical Lighting System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Communications
- Decided: Dec 30, 2013 after 118 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
Longest line of descent: 3 generations back to K922836 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101537: Aim 200, Major Surgical Light, Burton Medical Products Corp. (2010) Summary page 1.
- K060802: Visum Led Surgical Lighting System, Stryker Communications Corp. (2006) Summary page 1.

## Indications for use
The Visum Blade LED Surgical Light System (Blade) is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.

Source page: https://510kreport.com/device/K132747
Methodology: https://510kreport.com/methodology