# K940094: Colposcopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Leisegang Medical, Inc.
- Decided: Apr 25, 1995 after 473 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 (2003), 13 descendants of its own
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope (2013), 7 descendants of its own
- K981958: Leisegang Video Colposcope (1998), 6 descendants of its own
- K021854: DFV CPG Colposcope (2002), 4 descendants of its own
- K151878: Video Colposcope (2015), 2 descendants of its own

Source page: https://510kreport.com/device/K940094
Methodology: https://510kreport.com/methodology