# KRA: Catheter, Continuous Flush

- Device class: 2; regulation: 21 CFR 870.1210; FDA's rule: 510(k) required
- FDA decisions: 177
- 510(k) review time 2021–2025: median 159 days (middle half 60–209)
- Recalls: 123 (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)
- 2016: 8
- 2017: 4
- 2018: 4
- 2019: 4
- 2020: 6
- 2021: 6
- 2022: 6
- 2023: 7
- 2025: 1
- 2026: 5

## Most-cited predicates
- K000177: Renegade HI-Flo Microcatheter (2000), cited by 8
- K993672: Rebar Micro Catheter, Models 105-5080, 105-5086 (2000), cited by 8
- K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter (1993), cited by 6
- K030688: Echelon Micro Catheter, Model 105-5092-150 (2003), cited by 6
- K091559: Marksmann Catheter (2009), cited by 5
- K923368: Magic Infusion Catheter (1993), cited by 5
- K972518: Transit/Rapidtransit/Speedster/Prowler Infusion Catheter (1997), cited by 5
- K965181: Ces Infusion Catheter (1997), cited by 5
- K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips (2002), cited by 5
- K885281: Vamp Venous/Arterial Blood Management Protection (1989), cited by 4

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