# QNR: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

- Device class: 2; regulation: 21 CFR 870.4100; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 168 days (middle half 102–207)
- Recalls: 1 (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)
- 2021: 1
- 2022: 2
- 2023: 2
- 2024: 2
- 2025: 1

## Most-cited predicates
- K202751: TandemHeart Pump and Escort Controller (2021), cited by 2
- K211830: LifeSPARC System (2022), cited by 1
- K222038: CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (2022), cited by 1
- K230364: VitalFlow™ Console (2023), cited by 1

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