510(k) · Cleared
ClearedKarl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FCW Light Source, Fiberoptic, Routine
Cleared on Sep 14, 2009 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 14, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK091968 Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020CKARL STORZ Endoscopy-America, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK130819 CLL- V1 Light SourceOlympus Winter & Ibe GmbH · 2013
- Descendant · cites it directly · 1 of its ownK123956 Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK141164 Artemis Light EngineQuest Medical Imaging · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091968 | Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020C | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
| +1 | K130819 | CLL- V1 Light Source | Olympus Winter & Ibe GmbH | 2013 | — |
| +1 | K123956 | Power Led 175 | KARL STORZ Endoscopy-America, Inc. | 2013 | — |
| +2 | K141164 | Artemis Light Engine | Quest Medical Imaging | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCW? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K130819 (Olympus Winter & Ibe GmbH, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Karl Storz LED NOVA 100 Cold Light Fountain is indicated for use to transmit light through an optical cable to an endoscope in order to illuminate the site of surgery during minimally invasive endoscopic surgical procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091968 · printed Nov 3, 2026
Cite this page
510(k) Report. “K091968: Karl Storz Led Nova 100 Cold Light Fountain, Models 2016020, 20161020C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K091968
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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