# PSV: Ultrasound Bronchoscope

- Device class: 2; regulation: 21 CFR 892.1550; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2002: 1
- 2007: 1
- 2019: 1
- 2026: 2

## Most-cited predicates
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), cited by 3
- K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F (2019), cited by 2
- K021204: Olympus BF Type UM40 (2002), cited by 1

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