510(k) · Cleared
ClearedEndoscopic Light Source XL180/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 Jan 14, 2003 as substantially equivalent to K020889 (World of Medicine Lemke GmbH, 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jan 14, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932771 (1994). 7 ancestors in all, the oldest K934559 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK932771 Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
- 2 generations backK960081 Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996
- 1 generation backK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- This deviceK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −3 | K932771 | Battery Powered, Disposable Endoscope Light Source | Xomed-Treace, Inc. | 1994 | — |
| −2 | K960081 | Battery Powered Endosccopic Light Source | Mitsubishi Cable America, Inc. | 1996 | — |
| −1 | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| 0 (this device) | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +1 | 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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K020889 | Endoscopic Light Source XL202/L3Summary page 1…The device is described in 21 C.F.R. 9 876.1500. The product code for the device is GCT. IV. Predicate Device: e Endoscopic Light Source XL202/L3 (K020889) manufactured by WORLD OF MEDICINE Lemke GmbH e Endoscopic Light Source XL300/L5 (KO217 17) manufactured b… | 2002 |
| * | K021717 | Endoscopic Light Source, Model XL300/L5 | 2002 |
| * | K934559 | Karl Storz Xenon Light Source Model 201320-20Summary page 1…e Endoscopic Light Source XL300/L5 (KO217 17) manufactured by WORLD OF MEDICINE Lemke GmbH Karl Ston Xenon Light Source Model 201320-20 (K934559) manufactured by Karl Storz Endoscopy Imaging, Inc. V. Intended Use: The Endoscopic Light Source XLl8O/L… | 1994 |
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 |
|---|---|---|---|
| K032545 | Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250 | 2003 | 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K032545 (Mgb Endoskopische Gerate GmbH (Berlin), 2003) 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.
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 XL18OL3 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/K023468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023468: Endoscopic Light Source XL180/L3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023468
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