510(k) · Cleared

Cleared

DFV CPG Colposcope

K021854510(k) TraditionalCleared Oct 25, 2002141-day reviewClass II21 CFR 884.1630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

D.F. Vasconcellos S.A. · HEX Colposcope (And Colpomicroscope)

Cleared on Oct 25, 2002 as substantially equivalent to K000707 (Leica Microscopy Systems, Ltd., 2000) and 13 other predicates after a 141-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.

Decided: Oct 25, 2002
Review: 141 days
Class: Class II
Product code: HEX
Recalls: None
Predicates: 14

Its longest line of descent runs back 2 generations to K940094 (1995). 14 ancestors in all, the oldest K760763 (1976). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
1 generation backK981958 Leisegang Video ColposcopeNetoptix Corp. · 1998
This deviceK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
Descendant · cites it directly · 1 of its ownK070845 Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK160341 Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016
Descendant · cites it directly · 0 of its ownK101141 Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010
Descendant · cites it directly · 0 of its ownK061306 CO-1000 Colposcope, MultipleGynex Corp. · 2006

Most influential descendants

Showing 4 of 4 · See all

K070845Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007 · cites it directly1descendant
K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016 · 2 generations on0descendants
K101141Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010 · cites it directly0descendants
K061306CO-1000 Colposcope, MultipleGynex Corp. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K940094	Colposcopes and Accessories	Leisegang Medical, Inc.	1995	—
−1	K981958	Leisegang Video Colposcope	Netoptix Corp.	1998	—
0 (this device)	K021854	DFV CPG Colposcope	D.F. Vasconcellos S.A.	2002	—
+1	K070845	Sounmed Coloposcope Colpo-99/99PLUS	Sounmed, Inc.	2007	—
+2	K160341	Colposcope System	Xuzhou Kernel Medical Equipment Co., Ltd.	2016	—
+1	K101141	Seiler Colposcope, Models 935, 955 and 985	Seiler Precision Microscopes	2010	—
+1	K061306	CO-1000 Colposcope, Multiple	Gynex Corp.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1976	2	0
1977	2	0
1985	2	0
1987	1	0
1989	1	0
1994	1	0
1996	1	0
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2010	1	0
2016	1	0

FIG. 1 — Lineage of K021854, 1995–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HEX device

#1 K233043 Smart Scope® CXscore 8.4 · 4 generations · no Class I recall

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What was it cleared against? (14)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K000707	Leica Colposcope	Leica Microscopy Systems, Ltd.	2000	—
*	K981958	Leisegang Video Colposcope Summary page 1 …umber Leica Colposcope Leica Microscopy Systems KO00707 Leisegang Video Colposcope Netoptix Corp. K981958 IMT Loupe-Colposcope Inventive Medical Techno1 K963593 Video Colposcope/vertical…	Netoptix Corp.	1998	—
*	K963593	Imt Loupe-Colposcope Summary page 1 …00707 Leisegang Video Colposcope Netoptix Corp. K981958 IMT Loupe-Colposcope Inventive Medical Techno1 K963593 Video Colposcope/vertical Welch Allyn, Inc. K955635 Colposcopes and accessories…	Inventive Medical Technology	1997	—
*	K955635	Video Colposcope/Vertical Rolling Base/Swing Arm Stand Summary page 1 …81958 IMT Loupe-Colposcope Inventive Medical Techno1 K963593 Video Colposcope/vertical Welch Allyn, Inc. K955635 Colposcopes and accessories Leisegang Medical, Inc. K940094 HM-0690 Colposcope…	Welch Allyn, Inc.	1996	—
*	K940094	Colposcopes and Accessories Summary page 1 …63593 Video Colposcope/vertical Welch Allyn, Inc. K955635 Colposcopes and accessories Leisegang Medical, Inc. K940094 HM-0690 Colposcope Hill-Med, Inc. K932896 Jedmed KP6 Colposcope…	Leisegang Medical, Inc.	1995	—
*	K932896	HM-0690 Colposcope Summary page 1 …55635 Colposcopes and accessories Leisegang Medical, Inc. K940094 HM-0690 Colposcope Hill-Med, Inc. K932896 Jedmed KP6 Colposcope Jedmed Instrument Co. K884934 Wallach Convertible Colposcope…	Hill-Med, Inc.	1994	—
*	K884934	Jedmed KP6 Colposcope Summary page 1 …40094 HM-0690 Colposcope Hill-Med, Inc. K932896 Jedmed KP6 Colposcope Jedmed Instrument Co. K884934 Wallach Convertible Colposcope Wallach Surgical Devices K87 1682 Wallach Zoom Colposcope…	Jedmed Instrument Co.	1989	—
*	K871682	Wallach Convertible Colposcope Summary page 1 …32896 Jedmed KP6 Colposcope Jedmed Instrument Co. K884934 Wallach Convertible Colposcope Wallach Surgical Devices K87 1682 Wallach Zoom Colposcope Wallach Surgical Devices K853389 OCS-2 Colposcope…	Wallach Surgical Devices, Inc.	1987	—
*	K853389	Wallach Zoom Colposcope Summary page 1 …934 Wallach Convertible Colposcope Wallach Surgical Devices K87 1682 Wallach Zoom Colposcope Wallach Surgical Devices K853389 OCS-2 Colposcope Olympus Corp. K852980 Colposcope Model I1 D…	Wallach Surgical Devices, Inc.	1985	—
*	K852980	Ocs-2 Colposcope Summary page 1 …1682 Wallach Zoom Colposcope Wallach Surgical Devices K853389 OCS-2 Colposcope Olympus Corp. K852980 Colposcope Model I1 Dynatech Cryomedical Co. K770896 Colposcope System Rich…	Olympus Corp.	1985	—
*	K770896	Colposcope Model II Summary page 1 …53389 OCS-2 Colposcope Olympus Corp. K852980 Colposcope Model I1 Dynatech Cryomedical Co. K770896 Colposcope System Richard Wolf Medical Instruments K770697 Dynatech JD7/JD7P Colposcope D…	Dynatech Cryomedical Co.	1977	—
*	K770697	Colposcope System Summary page 1 …52980 Colposcope Model I1 Dynatech Cryomedical Co. K770896 Colposcope System Richard Wolf Medical Instruments K770697 Dynatech JD7/JD7P Colposcope Dynatech Cryomedical Co. K76 1205 Colposcope (Dynatech Colposcope)…	Richard Wolf Medical Instruments Corp.	1977	—
*	K761205	Dynatech JD7/JD7P Colposcope Summary page 1 …70896 Colposcope System Richard Wolf Medical Instruments K770697 Dynatech JD7/JD7P Colposcope Dynatech Cryomedical Co. K76 1205 Colposcope (Dynatech Colposcope) Dynatech Cryomedical Co. K760763 5 10 (k) notification…	Dynatech Cryomedical Co.	1976	—
*	K760763	Colposcope (Dynatech Colposcope-Model I Summary page 1 …0697 Dynatech JD7/JD7P Colposcope Dynatech Cryomedical Co. K76 1205 Colposcope (Dynatech Colposcope) Dynatech Cryomedical Co. K760763 5 10 (k) notification 615 5…	Dynatech Cryomedical Co.	1976	—

Also cleared against K000707: 1 other device →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070845	Sounmed Coloposcope Colpo-99/99PLUS	Sounmed, Inc.	2007	1
K101141	Seiler Colposcope, Models 935, 955 and 985	Seiler Precision Microscopes	2010	0
K061306	CO-1000 Colposcope, Multiple	Gynex Corp.	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K070845 (Sounmed, Inc., 2007) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K000707.

How does its category compare?

All HEX devices

HEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HEX

1in 2024

2007high 3 (2010) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HEX

165in 2016

2007high 211 (2014) · low 129 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HEX

No recall names HEX since 2007.

Adverse event reports per year · HEX

1in 2025

2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code HEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	1	—	2
2009	0	—	0
2010	3	129	0
2011	2	—	1
2012	0	—	0
2013	2	—	0
2014	3	211	2
2015	1	—	0
2016	3	165	0
2017	1	—	0
2018	2	—	0
2019	1	—	2
2020	0	—	1
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	1	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K021854 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021854: DFV CPG Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021854

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026