# FDT: Duodenoscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 94 days (middle half 81–178)
- Recalls: 15 (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: 1
- 2017: 2
- 2018: 3
- 2019: 5
- 2020: 4
- 2021: 2
- 2022: 1
- 2024: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K143153: Evis Exera II Duodenovideoscope Olympus TJF Type Q180V (2016), cited by 4
- K192245: Pentax Medical Video Duodenoscope ED34-i10T2 (2019), cited by 3
- K832006: Pentax FD-34A Duodenofiberscope (1983), cited by 2
- K191747: FUJIFILM Duodenoscope Model ED-580XT (2019), cited by 2
- K181522: PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (2018), cited by 2
- K110833: Cre Balloon Dilatation Catheter (2011), cited by 2
- K092710: Pentax ED-3490TK, Video Duodenoscope (2009), cited by 2
- K980465: Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers (1998), cited by 2
- K202661: Evis Exera III Duodenovideoscope Olympus TJF-Q190V (2020), cited by 2
- K152257: Fujifilm Duodenoscope Model ED-530XT (2017), cited by 2

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