# QYZ: At Home Intravaginal Insemination System

- Device class: 2; regulation: 21 CFR 884.6110; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 192 days (middle half 155–204)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2023: 3

## Most-cited predicates

Source page: https://510kreport.com/product-code/QYZ
Data by year (CSV): https://510kreport.com/product-code/QYZ.csv