510(k) · Cleared
ClearedEndoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mgb Endoskopische Gerate GmbH (Berlin) · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Sep 2, 2003 as substantially equivalent to K021717 (World of Medicine Lemke GmbH, 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 2, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932771 (1994). 8 ancestors in all, the oldest K934559 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK932771 Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
- 3 generations backK960081 Battery Powered Endosccopic Light SourceMitsubishi Cable America, Inc. · 1996
- 2 generations backK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- 1 generation backK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- This deviceK032545 Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180…Mgb Endoskopische Gerate GmbH (Berlin) · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932771 | Battery Powered, Disposable Endoscope Light Source | Xomed-Treace, Inc. | 1994 | — |
| −3 | K960081 | Battery Powered Endosccopic Light Source | Mitsubishi Cable America, Inc. | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 FET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021717 | Endoscopic Light Source, Model XL300/L5 | 2002 |
| * | K023468 | Endoscopic Light Source XL180/L3Summary page 2…oscopic Light Source XL3OO/L5 (KO2 1717), the LS-1800XG (Med Light X 180) is similar in design and technological characteristics to the Endoscopic Light Source XL18O/L3 (K023468) and the LS-2500H (Med Light H 250) is similar in design and technological characteristics to the Endoscopic Light Source XL202/L… | 2003 |
| Kept off the family tree | K020889 | FDA’s K020889 is Endoscopic Light Source XL202/L3 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K021717.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
Light Sources LS-1800XG (Med Light X l SO), LS-3OOOX, LS-2500H (Med Light H250) provide illumination for fiberoptic endoscopy to gastroenterological and urological cavities, hollow organs and canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032545: Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032545
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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