510(k) · Cleared
ClearedCO-1000 Colposcope, Multiple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynex Corp. · HEX Colposcope (And Colpomicroscope)
Cleared on Aug 7, 2006 as substantially equivalent to K021854 (D.F. Vasconcellos S.A., 2002) after an 89-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 7, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940094 (1995). 15 ancestors in all, the oldest K760763 (1976). No later device cites it as a predicate yet.
- Root · 3 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 2 generations backK981958 Leisegang Video ColposcopeNetoptix Corp. · 1998
- 1 generation backK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- This deviceK061306 CO-1000 Colposcope, MultipleGynex Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −2 | K981958 | Leisegang Video Colposcope | Netoptix Corp. | 1998 | — |
| −1 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K021854 | DFV CPG ColposcopeSummary page 1…materials, method of manufacture, physical dimensions, and clinical utility as the following legally marketed device: · DFV CPG Colposcope, K021854, DF Vasconcellos, SA 5. Device Description: The CO-1000 Colposcope is a precise optical instrument designed spe… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K021854.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HEX
165in 2016
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 129 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 211 | 0 | 2 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 165 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Gynex brand 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061306: CO-1000 Colposcope, Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061306
Report an extraction error
Are you the manufacturer?
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