510(k) · Cleared
ClearedKsea Clearvision Lens Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jan 16, 2002 after a 58-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jan 16, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK013838 Ksea Clearvision Lens Irrigation SystemKARL STORZ Endoscopy-America, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK072410 Ksea Clearvision II, Model 40334120KARL STORZ Endoscopy-America, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 2 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 3 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
- Descendant · cites it directly · 0 of its ownK261544 Hydro Irrigation SystemStryker Instruments · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072410Ksea Clearvision II, Model 40334120KARL STORZ Endoscopy-America, Inc. · 2008 · cites it directly4descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · cites it directly2descendants
- K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020 · 2 generations on1descendant
- K261706Endomat Select (UP220)Karl Storz SE & CO. KG · 2026 · 3 generations on0descendants
- K261544Hydro Irrigation SystemStryker Instruments · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013838 | Ksea Clearvision Lens Irrigation System | KARL STORZ Endoscopy-America, Inc. | 2002 | — |
| +1 | K072410 | Ksea Clearvision II, Model 40334120 | KARL STORZ Endoscopy-America, Inc. | 2008 | — |
| +1 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +2 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +3 | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
| +1 | K261544 | Hydro Irrigation System | Stryker Instruments | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 3 | 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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 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? (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 |
|---|---|---|---|
| * | — | Endo-suction/irrigation pump Named without a submission number |
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?
- Of its descendants, K072410 (KARL STORZ Endoscopy-America, Inc., 2008) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
The KSEA Clearvision® is a lens irrigation system for cleaning the lens and maintaining clear visualization without removing the scope from the surgical site during sinus surgery.
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/K013838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013838: Ksea Clearvision Lens Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013838
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026