510(k) · Cleared
ClearedEndoscopic Light Source XL202/L3
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 Jun 5, 2002 as substantially equivalent to K934559 (KARL STORZ Endoscopy-America, Inc., 1994) and 2 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 5, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K932771 (1994). 5 ancestors in all, the oldest K934559 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK932771 Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
- 1 generation backK960081 Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996
- This deviceK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- Descendant · cites it directly · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- Descendant · 2 generations on · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932771 | Battery Powered, Disposable Endoscope Light Source | Xomed-Treace, Inc. | 1994 | — |
| −1 | K960081 | Battery Powered Endosccopic Light Source | Mitsubishi Cable America, Inc. | 1996 | — |
| 0 (this device) | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| +1 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +2 | K032545 | Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med… | Mgb Endoskopische Gerate GmbH (Berlin) | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K934559 | Karl Storz Xenon Light Source Model 201320-20Summary page 1…s described in 21 C.F.R.$876.1500. The product code for the device is GCT. IV. Predicate Devices: Karl S t o a Xenon Light Source Model 201320-20(K934559) manufactured by Karl Storz Imaging, Inc. Xenon Light Source Auto Lip 5123,Model 2123.011 6983628)… | 1994 |
| * | K983628 | Xenon Light Source Auto Lip 5123, Model 2123.011Summary page 2…he Karl Storz Xenon Light Source Model 201320-20 (K934559) manufactured by Karl Storz Imaging, Inc. and the Xenon Light Source Auto Lip 5123, Model 2123.011 (K983628) manufiwtured by Richard WoEMedical Instruments Corp., the Battery Powered Endoscopic Light Source (K960081)manufactu… | 1998 |
| * | K960081 | Battery Powered Endosccopic Light SourceSummary page 2…Xenon Light Source Auto Lip 5123, Model 2123.011 (K983628) manufiwtured by Richard WoEMedical Instruments Corp., the Battery Powered Endoscopic Light Source (K960081)manufacturedby Mitsubishi Cable America, Inc., the LH -150manufactured by Pentax Precision Instrwnent Corp.and the CLE-SC… | 1996 |
| * | — | LH-150 Named without a submission number | |
| * | — | CLE-SC Halogen Light Source Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023468 | Endoscopic Light Source XL180/L3 | 2003 | 1 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K023468 (World of Medicine Lemke GmbH, 2003) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K934559.
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 XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020889: Endoscopic Light Source XL202/L3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020889
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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