510(k) · Cleared
ClearedColposcopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leisegang Medical, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Apr 25, 1995 after a 473-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it.
- Decided
- Apr 25, 1995
- Review
- 473 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 6 citing it directly.
- This deviceK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- Descendant · cites it directly · 13 of its ownK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- Descendant · 2 generations on · 7 of its ownK122973 AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK981958 Leisegang Video ColposcopeNetoptix Corp. · 1998
- Descendant · cites it directly · 4 of its ownK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- Descendant · 2 generations on · 2 of its ownK151878 Video ColposcopeEdan Instruments, Inc. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K021153Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003 · cites it directly13descendants
- K122973AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013 · 2 generations on7descendants
- K981958Leisegang Video ColposcopeNetoptix Corp. · 1998 · cites it directly6descendants
- K021854DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002 · cites it directly4descendants
- K151878Video ColposcopeEdan Instruments, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| +1 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| +2 | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope | Medgyn Products, Inc. | 2013 | — |
| +1 | K981958 | Leisegang Video Colposcope | Netoptix Corp. | 1998 | — |
| +1 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| +2 | K151878 | Video Colposcope | Edan Instruments, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | 2003 | 13 |
| K981958 | Leisegang Video Colposcope | 1998 | 6 |
| K021854 | DFV CPG Colposcope | 2002 | 4 |
| K140754 | Cooper Surgical Leisegang Colposcope System | 2014 | 1 |
| K972630 | Coopersurgical Digital Colposcopy System | 1998 | 1 |
| K101141 | Seiler Colposcope, Models 935, 955 and 985 | 2010 | 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?
- Of its descendants, K021153 (Goldway Us, Inc., 2003) has gone furthest, with 13 descendants of its own.
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 | — |
https://510kreport.com/device/K940094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940094: Colposcopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940094
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026