# QHW: Single Lumen Ecmo Cannula

- Device class: 2; regulation: 21 CFR 870.4100; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 343 days (middle half 198–488)
- 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)
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K201057: Bio-Medicus Life Support Catheter and Introducer (2022), cited by 2

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