# MKO: Falloposcope

- Device class: 2; regulation: 21 CFR 884.1690; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 255 days (middle half 255–255)
- Recalls: 0 (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)
- 1997: 2
- 1998: 1
- 2023: 1

## Most-cited predicates
- K962587: Conceptus Fallopian Tube Catheteization with Microendoscopy System (1997), cited by 1

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