510(k) · Cleared
ClearedClear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minimally Invasive Devices, LLC · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Nov 6, 2008 as substantially equivalent to K062779 (New Wave Surgical Corporation, 2006) and 1 other predicate after a 247-day review. Its family tree reaches back 3 generations to 1991. 16 later devices descend from it.
- Decided
- Nov 6, 2008
- Review
- 247 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904871 (1991). 18 ancestors in all, the oldest K902683 (1990). 16 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK904871 Medi-KleerNorth American Marketing Corp. · 1991
- 2 generations backK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- 1 generation backK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- This deviceK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- Descendant · cites it directly · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK192891 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019
- Descendant · 4 generations on · 3 of its ownK200228 ClearCam SystemClearcam, LLC · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · cites it directly8descendants
- K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 2 generations on7descendants
- K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 3 generations on6descendants
- K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019 · 4 generations on4descendants
- K200228ClearCam SystemClearcam, LLC · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| −2 | K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | 1997 | — |
| −1 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
| 0 (this device) | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008 | — |
| +1 | K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2015 | — |
| +2 | K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016 | — |
| +3 | K170103 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2017 | — |
| +4 | K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2019 | — |
| +4 | K200228 | ClearCam System | Clearcam, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 OCT? 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 OCT device
- #1 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…Summary page 4…he Clear—Vu System is substantially equivalent in terms of safety and effectiveness to the following predicate devices: 1. Defogging Heated Endoscopic Lens Protector / K062779 New Wave Surgical Cotp. 2. Endo-Scrub® 2 / K982594 Xomed, Inc. 3. SeeClear™ Laparoscopic Smoke Evacnauon System/510(k) Exempt J… | 2006 |
| * | K982594 | Endo-Scrub/Endo-Scrub 2Summary page 4…rms of safety and effectiveness to the following predicate devices: 1. Defogging Heated Endoscopic Lens Protector / K062779 New Wave Surgical Cotp. 2. Endo-Scrub® 2 / K982594 Xomed, Inc. 3. SeeClear™ Laparoscopic Smoke Evacnauon System/510(k) Exempt JLJ Medical Devices International, L1C The Clear-Vu… | 1998 |
| * | — | SeeClear™ Laparoscopic Smoke Evacuation System Named without a submission number |
What descends from it? (16)
See all 165 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 17 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K151117 (Medeon Biodesign, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K062779.
How does its category compare?
All OCT devicesOCT Anti Fog Solution And Accessories, Endoscopy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OCT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCT
Too few OCT 510(k)s in any year since 2007 to give a median.
Recalls per year · OCT
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCT
13in 2025
MAUDE reports naming product code OCT, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 27 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 1 | 10 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Clear-Vu is a single-use, disposable laparoscopic accessory device that is intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
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/K080613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080613
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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