# QEW: Peripheral Mechanical Thrombectomy With Aspiration

- Device class: 2; regulation: 21 CFR 870.5150; FDA's rule: 510(k) required
- FDA decisions: 146
- 510(k) review time 2021–2025: median 75 days (middle half 32–140)
- Recalls: 7 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 14
- 2019: 8
- 2020: 16
- 2021: 11
- 2022: 12
- 2023: 23
- 2024: 14
- 2025: 14
- 2026: 10

## Most-cited predicates
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (2015), cited by 9
- K213402: Triever24, Triever20 (2022), cited by 8
- K143563: Infusion Aspiration Catheter System (2015), cited by 7
- K212632: ClotTriever Thrombectomy System (2021), cited by 7
- K192833: Indigo Aspiration System (2019), cited by 4
- K192981: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 (2020), cited by 4
- K222358: Indigo Aspiration System - Lightning Flash (2022), cited by 4
- K180939: Indigo Aspiration System - Modified 110 Aspiration Tubing (2018), cited by 3
- K182531: ClotTriever Thrombectomy System (2018), cited by 3
- K161523: INDIGO Aspiration System (2016), cited by 3

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