# K111622: Unimax Anti-Fog Solution

- Pathway: 510(k) (Traditional)
- Applicant: Unimax Medical Systems, Inc.
- Decided: Sep 9, 2011 after 91 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: 2 generations back to K022826 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063587: Xodus Medical Anti-Fog Solution, Xodus Medical, Inc. (2007) Summary page 4.

## Indications for use
The Unimax Anti-Fog Solution is intended to be used to prevent “fogging” (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.

Source page: https://510kreport.com/device/K111622
Methodology: https://510kreport.com/methodology