510(k) · Cleared
Recalled · Class II · 2018Visum Led Surgical Lighting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Communications Corp. · FSY Light, Surgical, Ceiling Mounted
Cleared on Apr 7, 2006 as substantially equivalent to K031068 (Stryker Endoscopy, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Apr 7, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922836 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922836 ChromophareBerchtold Holding GmbH · 1992 · Recalled
- 1 generation backK031068 Stryker Visum Surgical Lighting SystemStryker Endoscopy · 2003 · Recalled
- This deviceK060802 Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006
- Descendant · cites it directly · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013
Most influential descendants
Showing 1 of 1 · See all- K132747Visum Blade Led Surgical Lighting SystemStryker Communications · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922836 | Chromophare | Berchtold Holding GmbH | 1992 | 1 |
| −1 | K031068 | Stryker Visum Surgical Lighting System | Stryker Endoscopy | 2003 | 8 |
| 0 (this device) | K060802 | Visum Led Surgical Lighting System | Stryker Communications Corp. | 2006 | — |
| +1 | K132747 | Visum Blade Led Surgical Lighting System | Stryker Communications | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K031068 | Stryker Visum Surgical Lighting SystemSummary page 1…s substantially equivalent in safety and efficacy to the currently marketed Stryker VisumTM Surgical lighting System, currently cleared under the pre-market notification K03 1068, and Med-General Technologies LLC's Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head (K042382) Surgica… | 2003 |
| * | K042382 | Dual Led Lite Engine with Illumination Led Cable Coupled to a Led Lite HeadSummary page 1…ently cleared under the pre-market notification K03 1068, and Med-General Technologies LLC's Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head (K042382) Surgical Lamp, currently cleared tinder K0423 82. The intended use of the Stryker VisumT M LED Surgical Lighting System is to i… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132747 | Visum Blade Led Surgical Lighting System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2018 | Class II | Z-1388-2019 | Employee error | There is a potential the joint in the suspension of the device is insufficiently assembled. |
| Feb 28, 2017 | Class II | Z-1699-2017 | Device Design | The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. |
| Nov 7, 2011 | Not classified | Z-0913-2012 | Nonconforming Material/Component | 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 could result in the light head beginning… |
| Aug 23, 2011 | Not classified | Z-0136-2012 | Process control | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K132747 (Stryker Communications, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031068.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 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 intended use of the Stryker Visum TM LED Surgical Lighting System is to illuminate
the operative site during surgical procedures with high intensity light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060802: Visum 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/K060802
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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