510(k) · Cleared
ClearedEndoscopic Light Source, Model XL300/L5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
World of Medicine Lemke GmbH · GCT Light Source, Endoscope, Xenon Arc
Cleared on Aug 20, 2002 after an 89-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Aug 20, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 4 citing it directly.
- This deviceK021717 Endoscopic Light Source, Model XL300/L5World of Medicine Lemke GmbH · 2002
- Descendant · cites it directly · 2 of its ownK031994 Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- Descendant · cites it directly · 0 of its ownK093125 Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
- Descendant · 2 generations on · 0 of its ownK070376 Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK032545 Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180…Mgb Endoskopische Gerate GmbH (Berlin) · 2003
Most influential descendants
Showing 5 of 5 · See all- K031994Linvatec 300W Xenon Light SourceLinvatec Corp. · 2003 · cites it directly2descendants
- K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · cites it directly1descendant
- K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010 · cites it directly0descendants
- K070376Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 2007 · 2 generations on0descendants
- K032545Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250Mgb Endoskopische Gerate GmbH (Berlin) · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021717 | Endoscopic Light Source, Model XL300/L5 | World of Medicine Lemke GmbH | 2002 | — |
| +1 | K031994 | Linvatec 300W Xenon Light Source | Linvatec Corp. | 2003 | 1 |
| +1 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +1 | K093125 | Alphaxenon Light 180 W and 300 W | Gimmi GmbH | 2010 | — |
| +2 | K070376 | Conmed Linvatec 300W Xenon Light Source | Conmed Linvatec | 2007 | 2 |
| +1 | K032545 | Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med… | Mgb Endoskopische Gerate GmbH (Berlin) | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K696259 | Karl Storz Xenon 300 Light Source for Non-Flash Applications Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…9 876.1500. The product code for the device is GCT. Iv. Predicate Device: 0 Karl Ston Xenon 300 Light Source for Non-FlashApplications 6962595) manufactured by Karl Storz Endoscopy-America, Inc. V. Intended Use: The Endoscopic Light Source XL300/L5is intende… |
What descends from it? (5)
4 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 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 Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to
provide illumination of body cavities, hollow organs and canals during endoscopic
procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021717: Endoscopic Light Source, Model XL300/L5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021717
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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