# K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045

- Pathway: 510(k) (Traditional)
- Applicant: Minimally Invasive Devices, LLC
- Decided: Nov 6, 2008 after 247 days
- Product code: OCT (Anti Fog Solution And Accessories, Endoscopy)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904871 (1991). 18 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp), New Wave Surgical Corporation (2006) Summary page 4.
- K982594: Endo-Scrub/Endo-Scrub 2, Xomed, Inc. (1998) Summary page 4.
- (no number) SeeClear™ Laparoscopic Smoke Evacuation System: named in the summary without a submission number

## Most influential descendants
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own
- K192891: Laparoscope Lens Shield Device (LENS) (2019), 4 descendants of its own
- K200228: ClearCam System (2020), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080613
Methodology: https://510kreport.com/methodology