# QJH: Reverse Central Venous Recanalization System

- Device class: 2; regulation: 21 CFR 870.1342; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 30 days (middle half 30–30)
- 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)
- 2020: 1
- 2025: 1

## Most-cited predicates
- DEN190038: Surfacer Inside-Out Access Catheter System (2020), cited by 1

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