510(k) · Cleared
ClearedKsea Clearvision II, Model 40334120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GWG Endoscope, Neurological
Cleared on May 9, 2008 as substantially equivalent to K982594 (Xomed, Inc., 1998) and 1 other predicate after a 256-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 256 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902683 (1990). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK902683 Scopescrubber (TM)Healthtek Microsurgical, Inc. · 1990
- 1 generation backK982594 Endo-Scrub/Endo-Scrub 2Xomed, Inc. · 1998 · Recalled
- This deviceK072410 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 ownK253679 Hydro Irrigation SystemStryker Instruments · 2026
Most influential descendants
Showing 4 of 4 · See all- 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
- K253679Hydro 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 |
|---|---|---|---|---|---|
| −2 | K902683 | Scopescrubber (TM) | Healthtek Microsurgical, Inc. | 1990 | — |
| −1 | K982594 | Endo-Scrub/Endo-Scrub 2 | Xomed, Inc. | 1998 | 1 |
| 0 (this device) | 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 | K253679 | Hydro Irrigation System | Stryker Instruments | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 2 | 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K982594 | Endo-Scrub/Endo-Scrub 2Summary page 1…Classification Name: Neurological endoscope. Regulation Number: 21 CFR 882.1480 Product Code: GWG Predicate Device(s): Xomed Endo-Scrub/Endo-Scrub 2 (K982594) KSEA Clearvision® Lens Irrigation System (K013838) Device Description: The KSEA Clearvision® II is a… | 1998 |
| * | K013838 | Ksea Clearvision Lens Irrigation SystemSummary page 1…CFR 882.1480 Product Code: GWG Predicate Device(s): Xomed Endo-Scrub/Endo-Scrub 2 (K982594) KSEA Clearvision® Lens Irrigation System (K013838) Device Description: The KSEA Clearvision® II is a microprocessor-controlled pump device. The device p… | 2002 |
What descends from it? (4)
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K180735 (Karl Storz SE & CO. KG, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K982594.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
The KSEA Clearvision II is a lens irrigation system for cleaning the distal lens of the telescope and maintaining clear visualization without removing the scope from the surgical site during endoscopic neurosurgical procedures using an endonasal approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072410: Ksea Clearvision II, Model 40334120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072410
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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