# K933529: Eyeglasses Frames

- Pathway: 510(k) (Traditional)
- Applicant: Vistula Assistance & Consulting Bureau
- Decided: Oct 20, 1993 after 92 days
- Product code: HQZ (Frame, Spectacle)
- Device class: 1
- Regulation: 21 CFR 886.5842
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 6, 2004 · Not classified · Z-0277-05: Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functiona

Source page: https://510kreport.com/device/K933529
Methodology: https://510kreport.com/methodology