# K932449: DR. FOG

- Pathway: 510(k) (Traditional)
- Applicant: O.R. Concepts, Inc.
- Decided: Aug 11, 1993 after 83 days
- Product code: OCT (Anti Fog Solution And Accessories, Endoscopy)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K231822: GOLFF Sterile Anti-Fog Solution (2024), 0 descendants of its own
- K190864: Konix Anti-Fog Solution (2020), 0 descendants of its own

## Recalls of this device
- May 15, 2005 · Not classified · Z-0897-05: An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
- Apr 30, 2003 · Not classified · Z-0828-03: Sterility compromised - incomplete sterile package seal.

Source page: https://510kreport.com/device/K932449
Methodology: https://510kreport.com/methodology