# JOP: Transducer, Ultrasonic

- Device class: 2; regulation: 21 CFR 870.2880; FDA's rule: 510(k) required
- FDA decisions: 72
- 510(k) review time 2021–2025: median 161 days (middle half 133–189)
- Recalls: 0 (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)
- 1995: 1
- 1999: 1
- 2000: 1
- 2001: 1
- 2007: 1
- 2011: 1
- 2013: 1
- 2014: 1
- 2016: 1
- 2024: 2

## Most-cited predicates
- K111416: Falcon (2011), cited by 4
- K990642: Echoflow Doppler Blood Velocity Meter (1999), cited by 1
- K861378: Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst (1986), cited by 1
- K870857: Abcom 1 Cardiac Output Monitor (1987), cited by 1
- K002766: Nicolet Vasoguard (2000), cited by 1
- K131623: Smartdop XT (2014), cited by 1

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