510(k) · Cleared
ClearedXenon Light Source Model 5121
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 Jul 25, 1995 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 25, 1995
- Review
- 42 days
- Class
- Class II
- Product code
- GCT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK952696 Xenon Light Source Model 5121Richard Wolf Medical Instruments Corp. · 1995
- Descendant · cites it directly · 6 of its ownK983628 Xenon Light Source Auto Lip 5123, Model 2123.011Richard Wolf Medical Instruments Corp. · 1998
- Descendant · 2 generations on · 2 of its ownK020889 Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
- Descendant · 2 generations on · 1 of its ownK121724 Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
- Descendant · 3 generations on · 1 of its ownK023468 Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
- Descendant · 3 generations on · 0 of its ownK131226 Novaprobe Led Light SourceNovaprobe Incorporated · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K983628Xenon Light Source Auto Lip 5123, Model 2123.011Richard Wolf Medical Instruments Corp. · 1998 · cites it directly6descendants
- K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002 · 2 generations on2descendants
- K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012 · 2 generations on1descendant
- K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003 · 3 generations on1descendant
- K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952696 | Xenon Light Source Model 5121 | Richard Wolf Medical Instruments Corp. | 1995 | — |
| +1 | K983628 | Xenon Light Source Auto Lip 5123, Model 2123.011 | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +2 | K020889 | Endoscopic Light Source XL202/L3 | World of Medicine Lemke GmbH | 2002 | — |
| +2 | K121724 | Endolight Led 1.1 Endolightled 1.2 | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +3 | K023468 | Endoscopic Light Source XL180/L3 | World of Medicine Lemke GmbH | 2003 | — |
| +3 | K131226 | Novaprobe Led Light Source | Novaprobe Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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, K983628 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K952696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952696: Xenon Light Source Model 5121.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952696
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026