# K190864: Konix Anti-Fog Solution

- Pathway: 510(k) (Traditional)
- Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
- Decided: Aug 27, 2020 after 512 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: 1 generation back to K932449 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932449: DR. FOG, O.R. Concepts, Inc. (1993) Summary page 4.

## Indications for use
KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K190864
Methodology: https://510kreport.com/methodology