510(k) · Cleared
ClearedCLL- V1 Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · NTN Led Light Source
Cleared on Jun 19, 2013 as substantially equivalent to K082813 (Stryker Corp., 2008) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 19, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- NTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961971 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 1 generation backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- This deviceK130819 CLL- V1 Light SourceOlympus Winter & Ibe GmbH · 2013
- Descendant · cites it directly · 0 of its ownK141164 Artemis Light EngineQuest Medical Imaging · 2015
Most influential descendants
Showing 1 of 1 · See all- K141164Artemis Light EngineQuest Medical Imaging · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −1 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| 0 (this device) | K130819 | CLL- V1 Light Source | Olympus Winter & Ibe GmbH | 2013 | — |
| +1 | K141164 | Artemis Light Engine | Quest Medical Imaging | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 NTN? 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? (2)
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 |
|---|---|---|---|
| * | K082813 | Stryker Led LightsourceSummary page 2…urce 21 CFR 876.1500 Class Il NTN, FCW Gastroenterology/Urology Device Name: Stryker L9000 Storz LED Nova 100 Cold Light Fountain Manufacturer: Stryker 510(k) No.: K082813 Karl Storz K091968 244 K130819 4 Description of device The Olympus CLL-V1 is a desk top device which consists… | 2008 |
| * | K091968 | Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020CSummary page 2…0 Class Il NTN, FCW Gastroenterology/Urology Device Name: Stryker L9000 Storz LED Nova 100 Cold Light Fountain Manufacturer: Stryker 510(k) No.: K082813 Karl Storz K091968 244 K130819 4 Description of device The Olympus CLL-V1 is a desk top device which consists of a LED light sour… | 2009 |
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 |
|---|---|---|---|
| K141164 | Artemis Light Engine | 2015 | 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 17 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K141164 (Quest Medical Imaging, 2015) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K082813.
How does its category compare?
All NTN devicesNTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NTN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NTN
Too few NTN 510(k)s in any year since 2007 to give a median.
Recalls per year · NTN
No recall names NTN since 2007.
Adverse event reports per year · NTN
42in 2025
MAUDE reports naming product code NTN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 47 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 42 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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/K130819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130819: CLL- V1 Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130819
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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