# EOX: Esophagoscope (Flexible Or Rigid)

- Device class: 2; regulation: 21 CFR 874.4710; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 73 days (middle half 38–106)
- Recalls: 2 (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)
- 2013: 1
- 2014: 1
- 2016: 1
- 2018: 2
- 2019: 2
- 2020: 1
- 2021: 2
- 2022: 2
- 2023: 1
- 2024: 1

## Most-cited predicates
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System (2003), cited by 8
- K072088: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems (2007), cited by 4
- K142695: Cytosponge Cell Collection Device (2014), cited by 3
- K934193: Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst (1993), cited by 2
- K181020: Cytosponge Cell Collection Device (2018), cited by 2
- K152794: Cytosponge Cell Collection Device (2016), cited by 2
- K911588: Brandt Esophageal Cytology Balloon (1992), cited by 2
- K051972: Karl Storz Trans-Nasal Esophagoscope (2005), cited by 2
- K183262: EsoCheck CCD Cell Collection Device (2019), cited by 1
- K222366: EsoCheck Cell Collection Device (2022), cited by 1

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