# K231822: GOLFF Sterile Anti-Fog Solution

- Pathway: 510(k) (Traditional)
- Applicant: Batrik Medical Manufacturing, Inc.
- Decided: Feb 26, 2024 after 250 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). 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)
- K932449: DR. FOG, O.R. Concepts, Inc. (1993) Summary page 5.
- K152948: Medline Anti-Fog Solution, Medline Industries, Inc. (2016) Summary page 5.

## Indications for use
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.

Source page: https://510kreport.com/device/K231822
Methodology: https://510kreport.com/methodology