510(k) · Cleared
ClearedXenon Light Source Auto Lip 5123, Model 2123.011
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCT Light Source, Endoscope, Xenon Arc
Cleared on Dec 11, 1998 as substantially equivalent to K952696 (Richard Wolf Medical Instruments Corp., 1995) after a 57-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952696 (1995). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK952696 Xenon Light Source Model 5121Richard Wolf Medical Instruments Corp. · 1995
- This deviceK983628 Xenon Light Source Auto Lip 5123, Model 2123.011Richard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 2 of its ownK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- Descendant · cites it directly · 1 of its ownK121724 Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
- Descendant · 2 generations on · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- Descendant · 2 generations on · 0 of its ownK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
- Descendant · cites it directly · 0 of its ownK080809 Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002 · cites it directly2descendants
- K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012 · cites it directly1descendant
- K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · 2 generations on1descendant
- K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014 · 2 generations on0descendants
- K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952696 | Xenon Light Source Model 5121 | Richard Wolf Medical Instruments Corp. | 1995 | — |
| 0 (this device) | K983628 | Xenon Light Source Auto Lip 5123, Model 2123.011 | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| +1 | K121724 | Endolight Led 1.1 Endolightled 1.2 | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +2 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +2 | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
| +1 | K080809 | Iec Medsight and Medbright | Innovative Endoscopy Components, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952696 | Xenon Light Source Model 5121Summary page 1…Projector 5123.011 Comimon name: lassification Name: Xenon Light Source ls(enon Light Source Trade or proprietary or model name Manufacturer 1 Richard Wolf M.I.C. 1 K952696 1 Xenon Light Source 2 2 3 1.0 Description Light Projector AUTO LP 5123 uses a xenon arc lamp to provide illumination for an e… | 1995 |
What descends from it? (6)
3 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?
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?
Light Projector AUTO LP 5123 provides light for examination, diagnostic and therapeutic applications, in particular, in endoscopy.
The Xenon Light Source is classified as Cardiac Floating (CF) which permits its use for cardiac procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983628: Xenon Light Source Auto Lip 5123, Model 2123.011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983628
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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