# FET: Endoscopic Video Imaging System/Component, Gastroenterology-Urology

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 101
- 510(k) review time 2021–2025: median 155 days (middle half 109–194)
- 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)
- 2017: 3
- 2018: 3
- 2019: 3
- 2020: 5
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 2
- 2025: 6
- 2026: 3

## Most-cited predicates
- K934918: Epm-3300 Video Processor (1994), cited by 12
- K954451: Evis 140 System (1996), cited by 10
- K163675: Processor VP-7000, Light Source BL-7000 (2017), cited by 5
- K944620: Series 400 Gastroenterology System (1995), cited by 5
- K023659: 1-CCD Endocam 5520 System (2003), cited by 4
- K012660: Gimmi'alpha' Endoscopes & Accessories (2001), cited by 4
- K102466: Fujinon Epx-4440HD Digital Video Processor (2011), cited by 4
- K944759: 200 Series Gastro-Intestinal Video System (1995), cited by 4
- K853585: Olympus Evs-Endoscopic Video Image & Data Sys (1986), cited by 4
- K003325: Ksi's New Camera Architecture (Nca) Video Imaging System (2001), cited by 3

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