# HEX: Colposcope (And Colpomicroscope)

- Device class: 2; regulation: 21 CFR 884.1630; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 263 days (middle half 263–263)
- 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)
- 2010: 3
- 2011: 2
- 2013: 2
- 2014: 3
- 2015: 1
- 2016: 3
- 2017: 1
- 2018: 2
- 2019: 1
- 2024: 1

## Most-cited predicates
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand (1996), cited by 8
- K940094: Colposcopes and Accessories (1995), cited by 6
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope (2013), cited by 5
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 (2003), cited by 5
- K853389: Wallach Zoom Colposcope (1985), cited by 4
- K021854: DFV CPG Colposcope (2002), cited by 3
- K884934: Jedmed KP6 Colposcope (1989), cited by 2
- K000707: Leica Colposcope (2000), cited by 2
- K981958: Leisegang Video Colposcope (1998), cited by 2
- K031639: Intermed Zoom Colposcope (2003), cited by 2

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