510(k) · Cleared
Recalled · 2011Stryker Visum Surgical Lighting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FSY Light, Surgical, Ceiling Mounted
Cleared on Aug 12, 2003 as substantially equivalent to K922836 (Berchtold Holding GmbH, 1992) after a 130-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 12, 2003
- Review
- 130 days
- Class
- Class II
- Product code
- FSY
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922836 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922836 ChromophareBerchtold Holding GmbH · 1992 · Recalled
- This deviceK031068 Stryker Visum Surgical Lighting SystemStryker Endoscopy · 2003
- Descendant · cites it directly · 1 of its ownK060802 Visum Led Surgical Lighting SystemStryker Communications Corp. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK132551 ZF 720Umbel Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK132747 Visum Blade Led Surgical Lighting SystemStryker Communications · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922836 | Chromophare | Berchtold Holding GmbH | 1992 | 1 |
| 0 (this device) | K031068 | Stryker Visum Surgical Lighting System | Stryker Endoscopy | 2003 | — |
| +1 | K060802 | Visum Led Surgical Lighting System | Stryker Communications Corp. | 2006 | 4 |
| +1 | K132551 | ZF 720 | Umbel Corporation | 2014 | — |
| +2 | K132747 | Visum Blade Led Surgical Lighting System | Stryker Communications | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K922836 | ChromophareSummary page 1…Visumm Surgical Lighting System Predicate Device Berchtold D650 Surgical Lighting System, currently marketed by Berchtold Corporation under the pre- market notification K922836. Indications for Use: The intended use of the Stryker VisumTM Surgical Lighting System is to illuminate the operative site durin… | 1992 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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-0137-2012 | Process control | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. |
| Apr 15, 2010 | Not classified | Z-1641-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1643-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1640-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1645-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1642-2010 | Employee error | Installation records are incomplete. |
| Apr 15, 2010 | Not classified | Z-1644-2010 | Employee error | Installation records are incomplete. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Visumm 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/K031068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031068: Stryker Visum 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/K031068
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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