510(k) · Cleared
Recalled · 2005Linvatec 300W Xenon Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Aug 21, 2003 as substantially equivalent to K962595 (KARL STORZ Endoscopy-America, Inc., 1996) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 2003
- Review
- 55 days
- Class
- Class II
- Product code
- GCT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K962595 (1996). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962595 Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsKARL STORZ Endoscopy-America, Inc. · 1996
- This deviceK031994 Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003
- Descendant · cites it directly · 0 of its ownK093125 Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
- Descendant · cites it directly · 0 of its ownK070376 Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962595 | Karl Storz Xenon 300 Light Source for Non-Flash Applications | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| 0 (this device) | K031994 | Linvatec 300W Xenon Light Source | Linvatec Corp. | 2003 | — |
| +1 | K093125 | Alphaxenon Light 180 W and 300 W | Gimmi GmbH | 2010 | — |
| +1 | K070376 | Conmed Linvatec 300W Xenon Light Source | Conmed Linvatec | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 GCT? 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 |
|---|---|---|---|
| * | K962595 | Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsSummary page 2…The Linvatec 300W Xenon Light Source described in this notification is similar in design, technology and intended use to the Karl Storz 300 Xenon Light Source (K962595) and the World of Medicine Lemke GMBH Model XL3OO/L5 Light Source (K021717). The differences between the Linvatec 300W… | 1996 |
| * | K021717 | Endoscopic Light Source, Model XL300/L5Summary page 2…lar in design, technology and intended use to the Karl Storz 300 Xenon Light Source (K962595) and the World of Medicine Lemke GMBH Model XL3OO/L5 Light Source (K021717). The differences between the Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new qu… | 2002 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Aug 1, 2005 | Not classified | Z-1531-05 | Nonconforming Material/Component | Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GCT devicesGCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GCT
Too few GCT 510(k)s in any year since 2007 to give a median.
Recalls per year · GCT
No recall names GCT since 2007.
Adverse event reports per year · GCT
347in 2025
MAUDE reports naming product code GCT, 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 | 1 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 0 | 132 |
| 2012 | 0 | — | 0 | 36 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 149 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 0 | 200 |
| 2024 | 0 | — | 0 | 296 |
| 2025 | 0 | — | 0 | 347 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031994: Linvatec 300W Xenon Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031994
Report an extraction error
Are you the manufacturer?
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