510(k) · Cleared
ClearedXenon-100 SCB Light Source, Model 20132620
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Dec 18, 2008 after a 78-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Dec 18, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK082925 Xenon-100 SCB Light Source, Model 20132620KARL STORZ Endoscopy-America, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK201096 CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082925 | Xenon-100 SCB Light Source, Model 20132620 | KARL STORZ Endoscopy-America, Inc. | 2008 | — |
| +1 | K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K201096 | CO2mbiLED | 2020 | 0 |
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, K201096 (Karl Storz Endoscopy America, Inc., 2020) has gone furthest, with 0 descendants of its own.
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. 2008, 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 KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082925: Xenon-100 SCB Light Source, Model 20132620.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082925
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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