# FER: Anoscope And Accessories

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 262 days (middle half 189–320)
- 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)
- 2010: 1
- 2011: 2
- 2012: 2
- 2013: 1
- 2014: 1
- 2017: 1
- 2021: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K070913: Self-Light Disposable Anoscope (2007), cited by 5
- K110792: Gelpoint Path (2011), cited by 3
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes (2011), cited by 2
- K020702: O'regan Disposable Anoscope (2002), cited by 2
- K080132: THD Disposable Anoscope/Proctoscope (2008), cited by 2
- K993738: Dispos-a-Scope (2000), cited by 1
- K091490: Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes (2009), cited by 1
- K133393: Gelpoint Path Transanal Access Platform (2014), cited by 1
- K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope (2012), cited by 1
- K994130: Rectosight RS 300-04 (2000), cited by 1

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