510(k) · Cleared
ClearedKarl Storz Xenon 300 Light Source for Non-Flash Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on Sep 4, 1996 after a 64-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Sep 4, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK962595 Karl Storz Xenon 300 Light Source for Non-Flash ApplicationsKARL STORZ Endoscopy-America, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK031994 Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK123956 Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK141164 Artemis Light EngineQuest Medical Imaging · 2015
- Descendant · cites it directly · 0 of its ownK093125 Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
- Descendant · cites it directly · 0 of its ownK080809 Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031994Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · cites it directly2descendants
- K123956Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013 · cites it directly1descendant
- K141164Artemis Light EngineQuest Medical Imaging · 2015 · 2 generations on0descendants
- K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010 · cites it directly0descendants
- K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +1 | K123956 | Power Led 175 | KARL STORZ Endoscopy-America, Inc. | 2013 | — |
| +2 | K141164 | Artemis Light Engine | Quest Medical Imaging | 2015 | — |
| +1 | K093125 | Alphaxenon Light 180 W and 300 W | Gimmi GmbH | 2010 | — |
| +1 | K080809 | Iec Medsight and Medbright | Innovative Endoscopy Components, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 FFS? 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?
The FDA summary names no predicate by number.
What descends from it? (6)
5 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031994 (Linvatec Corp., 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, 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 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is designed to supply light for endoscopic diagnostic and surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962595
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