# OWQ: Reprocessed Intravascular Ultrasound Catheter

- Device class: 2; regulation: 21 CFR 870.1200; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 114 days (middle half 64–150)
- Recalls: 3 (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)
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 3
- 2020: 1
- 2022: 2
- 2023: 8
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K210655: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (2022), cited by 1
- K222217: ViewFlex Xtra Reprocessed ICE Catheter (2022), cited by 1
- K231588: ViewFlex™ Eco Reprocessed ICE Catheter (2023), cited by 1
- K153090: Reprocessed Diagnostic Ultrasound Catheter (2016), cited by 1
- K110076: Reprocessed 3D Diagnostic Ultrasound Catheter (2011), cited by 1
- K230934: ViewFlex™ Eco Reprocessed ICE Catheter (2023), cited by 1
- K173262: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (2018), cited by 1
- K182238: Reprocessed ViewFlex Xtra ICE Catheter (2019), cited by 1

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