# OCX: Endoscopic Irrigation/Suction System

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 93
- 510(k) review time 2021–2025: median 109 days (middle half 81–217)
- Recalls: 16 (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)
- 2015: 2
- 2016: 2
- 2018: 5
- 2019: 8
- 2020: 4
- 2021: 3
- 2022: 6
- 2023: 7
- 2024: 4
- 2025: 4

## Most-cited predicates
- K031773: Endo Gator System (2003), cited by 5
- K102855: Universal Irrigation Solution Hybrid (2010), cited by 5
- K060962: Endogator Endoscopy Irrigation Pump, Model Egp-100 (2006), cited by 5
- K111821: Biopsy Valve (2011), cited by 4
- K971125: Endo Smartcap (100501) (1997), cited by 3
- K103235: Erbeflo 2 Disposable Tubing System (2010), cited by 3
- K030765: Hobbs Mistifier Spray Catheter (2003), cited by 2
- K161167: Seal Single-Use Biopsy Valve (2016), cited by 2
- K202616: ClearCap Distal Attachment (2021), cited by 2
- K181509: Endorate Valve Sets (2018), cited by 2

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