# ODC: Endoscope Channel Accessory

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 72
- 510(k) review time 2021–2025: median 126 days (middle half 48–214)
- 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)
- 2017: 1
- 2018: 2
- 2019: 4
- 2020: 4
- 2021: 6
- 2022: 8
- 2023: 7
- 2024: 8
- 2025: 6
- 2026: 1

## Most-cited predicates
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R) (2009), cited by 9
- K102409: Defendo Disposable Air/Water Valve Model 100304 (2010), cited by 9
- K102581: Defendo Disposable Suction Valve Model 100305 (2010), cited by 9
- K200769: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (2021), cited by 3
- K173105: Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter (2018), cited by 3
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (2021), cited by 3
- K220210: Disposable Endoscopy Adapter Set (2022), cited by 3
- K202104: BioGuard EUS Air/Water and Suction Valves (2021), cited by 2
- K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 (2001), cited by 2
- K110291: Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device (2011), cited by 2

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