510(k) · Cleared
Recalled · Class II · 2011Conmed Linvatec 300W Xenon Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · GCT Light Source, Endoscope, Xenon Arc
Cleared on Aug 20, 2007 as substantially equivalent to K031994 (Linvatec Corp., 2003) and 1 other predicate after a 193-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 2 times.
- Decided
- Aug 20, 2007
- Review
- 193 days
- Class
- Class II
- Product code
- GCT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962595 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK962595 Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsKARL STORZ Endoscopy-America, Inc. · 1996
- 1 generation backK031994 Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · Recalled
- This deviceK070376 Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962595 | Karl Storz Xenon 300 Light Source for Non-Flash Applications | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| −1 | K031994 | Linvatec 300W Xenon Light Source | Linvatec Corp. | 2003 | 1 |
| 0 (this device) | K070376 | Conmed Linvatec 300W Xenon Light Source | Conmed Linvatec | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K031994 | Linvatec 300W Xenon Light SourceSummary page 2…d Effectiveness Device Name 510(k)# / bo ? Date Page 2 of 2 D. Predicate/Legally Marketed Devices Linvatec Corporation Xenon 300W Light Source 510(k) #K031994 Karl Storz Endoscopy Xenon 300W Light Source 510(k) #K962595 E. Device Description The ConMed Linvatec 300W… | 2003 |
| * | K962595 | Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsSummary page 2…/Legally Marketed Devices Linvatec Corporation Xenon 300W Light Source 510(k) #K031994 Karl Storz Endoscopy Xenon 300W Light Source 510(k) #K962595 E. Device Description The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conj… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2011 | Class II | Z-2455-2012 | Nonconforming Material/Component | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic… |
| May 20, 2011 | Class II | Z-2456-2012 | Nonconforming Material/Component | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K031994.
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. 2007, this device’s year, is highlighted.
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 ConMed 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/K070376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070376: Conmed 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/K070376
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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