# K102452: Defogging and Cleaning Solution- Flo-X

- Pathway: 510(k) (Traditional)
- Applicant: Minimally Invasive Devices, LLC
- Decided: Dec 23, 2010 after 118 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: 4 generations back to K904871 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982465: Deroyal Industries, Inc. Defogger, Deroyal Industries, Inc. (1998) Summary page 4.
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045, Minimally Invasive Devices, LLC (2008) Summary page 4.

## Cited in the summary but kept off the family tree
- K054249: Covidien Auto-Suture Anti-Fog Solution (Dexide FRED). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.

Source page: https://510kreport.com/device/K102452
Methodology: https://510kreport.com/methodology