510(k) · Cleared

Cleared

Visum Blade Led Surgical Lighting System

K132747510(k) TraditionalCleared Dec 30, 2013118-day reviewClass II21 CFR 878.4580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Communications · FSY Light, Surgical, Ceiling Mounted

Cleared on Dec 30, 2013 as substantially equivalent to K101537 (Burton Medical Products Corp., 2010) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 1992.

Decided: Dec 30, 2013
Review: 118 days
Class: Class II
Product code: FSY
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K922836 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK922836 ChromophareBerchtold Holding GmbH · 1992 · Recalled
2 generations backK031068 Stryker Visum Surgical Lighting SystemStryker Endoscopy · 2003 · Recalled
1 generation backK060802 Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · Recalled
This deviceK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922836	Chromophare	Berchtold Holding GmbH	1992	1
−2	K031068	Stryker Visum Surgical Lighting System	Stryker Endoscopy	2003	8
−1	K060802	Visum Led Surgical Lighting System	Stryker Communications Corp.	2006	4
0 (this device)	K132747	Visum Blade Led Surgical Lighting System	Stryker Communications	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2010	1	0

FIG. 1 — Lineage of K132747, 1992–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K101537	Aim 200, Major Surgical Light Summary page 1 …FDA Regulation Number: 21 CFR 878.4580 Device Classification: Class 11 Predicate Devices: Burton's AIM 200 OR Major Surgical Light (K 10 1537). Stryker's Visurn LED Surgical Light System (K060802) Device Common Name: Surgic…	Burton Medical Products Corp.	2010	—
*	K060802	Visum Led Surgical Lighting System Summary page 1 …11 Predicate Devices: Burton's AIM 200 OR Major Surgical Light (K 10 1537). Stryker's Visurn LED Surgical Light System (K060802) Device Common Name: Surgical Light, Surgical Lamp Product Code: FSY FDA Regulation Number:…	Stryker Communications Corp.	2006	4

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
3 of the 6 ancestors have a recall of any class.

How does its category compare?

All FSY devices

FSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FSY

7in 2014

2007high 7 (2014) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FSY

59in 2014

2007high 130 (2010) · low 29 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FSY

11in 2023

2007high 228 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FSY

286in 2025

2007high 663 (2023) · low 40 (2009)2025

MAUDE reports naming product code FSY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	29	0	70
2008	2	—	0	53
2009	2	—	4	40
2010	5	130	3	72
2011	0	—	4	70
2012	2	—	4	171
2013	3	118	1	137
2014	7	59	0	139
2015	0	—	228	175
2016	0	—	0	182
2017	0	—	0	162
2018	0	—	2	316
2019	0	—	4	444
2020	0	—	0	439
2021	0	—	0	380
2022	0	—	0	430
2023	0	—	11	663
2024	0	—	0	541
2025	0	—	0	286
2026	0	—	4	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132747: Visum Blade Led Surgical Lighting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132747

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026