# NRY: Catheter, Thrombus Retriever

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 117
- 510(k) review time 2021–2025: median 122 days (middle half 56–179)
- Recalls: 12 (4 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: 3
- 2018: 11
- 2019: 7
- 2020: 6
- 2021: 9
- 2022: 3
- 2023: 8
- 2024: 8
- 2025: 15
- 2026: 14

## Most-cited predicates
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054 (2009), cited by 11
- K072718: Penumbra System (2007), cited by 7
- K113163: Penumbra System Max (2011), cited by 7
- K162901: Penumbra 3D Revascularization Device (2017), cited by 6
- K161640: Penumbra System ACE 68 Reperfusion Catheter (2016), cited by 6
- K113455: Solitaire FR Revascularization Device (2012), cited by 5
- K161064: Penumbra System ACE 68 Reperfusion Catheter (2016), cited by 5
- K203592: Tigertriever and Tigertriever 17 Revascularization Devce (2021), cited by 4
- K153071: Solitaire Platinum Revascularization Device (2015), cited by 4
- K142458: Penumbra System ACE (2015), cited by 4

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