# K021854: DFV CPG Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: D.F. Vasconcellos S.A.
- Decided: Oct 25, 2002 after 141 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
Longest line of descent: 2 generations back to K940094 (1995). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000707: Leica Colposcope, Leica Microscopy Systems, Ltd. (2000)
- K981958: Leisegang Video Colposcope, Netoptix Corp. (1998) Summary page 1.
- K963593: Imt Loupe-Colposcope, Inventive Medical Technology (1997) Summary page 1.
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 1.
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 1.
- K932896: HM-0690 Colposcope, Hill-Med, Inc. (1994) Summary page 1.
- K884934: Jedmed KP6 Colposcope, Jedmed Instrument Co. (1989) Summary page 1.
- K871682: Wallach Convertible Colposcope, Wallach Surgical Devices, Inc. (1987) Summary page 1.
- K853389: Wallach Zoom Colposcope, Wallach Surgical Devices, Inc. (1985) Summary page 1.
- K852980: Ocs-2 Colposcope, Olympus Corp. (1985) Summary page 1.
- K770896: Colposcope Model II, Dynatech Cryomedical Co. (1977) Summary page 1.
- K770697: Colposcope System, Richard Wolf Medical Instruments Corp. (1977) Summary page 1.
- K761205: Dynatech JD7/JD7P Colposcope, Dynatech Cryomedical Co. (1976) Summary page 1.
- K760763: Colposcope (Dynatech Colposcope-Model I, Dynatech Cryomedical Co. (1976) Summary page 1.

## Most influential descendants
- K070845: Sounmed Coloposcope Colpo-99/99PLUS (2007), 1 descendant of its own
- K160341: Colposcope System (2016), 0 descendants of its own
- K101141: Seiler Colposcope, Models 935, 955 and 985 (2010), 0 descendants of its own
- K061306: CO-1000 Colposcope, Multiple (2006), 0 descendants of its own

## Indications for use
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix. The patient’s population for which the Colposcope is intended is any person of the feminine sex.

Source page: https://510kreport.com/device/K021854
Methodology: https://510kreport.com/methodology