# FEB: Accessories, Cleaning, For Endoscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 62 days (middle half 34–125)
- Recalls: 29 (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)
- 2014: 1
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 2
- 2020: 2
- 2022: 1
- 2023: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K914145: DSD-91(TM) Disinfector for Flexible Endoscopes (1994), cited by 5
- K061899: Evotech Integrated Endoscope Disinfection System (2006), cited by 4
- K082988: Medivators Advantage Plus Endoscope Reprocessing System, Rapicide PA High Level Disinfectant (2009), cited by 4
- K103264: Endoscope Reprocessor Oer-Pro Model Oer-Pro (2011), cited by 3
- K914524: Fluid Pump, CP #3 (1994), cited by 2
- K000216: PSK Endoscope Cleaning System (2000), cited by 1
- K040883: Evotech Integrated Endoscope Disinfection System (2005), cited by 1
- K063876: Modular Disinfection System (MDS) for Endoscope Reprocessing (2007), cited by 1
- K082392: Evotech Endoscope Cleaner and Reprocessor (2008), cited by 1
- K173590: System 83 Plus Washer/Disinfector (2020), cited by 1

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