510(k) · Cleared
ClearedLeisegang Video Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Netoptix Corp. · HEX Colposcope (And Colpomicroscope)
Cleared on Oct 19, 1998 as substantially equivalent to K940094 (Leisegang Medical, Inc., 1995) and 1 other predicate after a 137-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Oct 19, 1998
- Review
- 137 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940094 (1995). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- This deviceK981958 Leisegang Video ColposcopeNetoptix Corp. · 1998
- Descendant · cites it directly · 4 of its ownK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- Descendant · cites it directly · 1 of its ownK140754 Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK101141 Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021854DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002 · cites it directly4descendants
- K140754Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014 · cites it directly1descendant
- K070845Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007 · 2 generations on1descendant
- K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016 · 2 generations on0descendants
- K101141Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| 0 (this device) | K981958 | Leisegang Video Colposcope | Netoptix Corp. | 1998 | — |
| +1 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| +1 | K140754 | Cooper Surgical Leisegang Colposcope System | CooperSurgical, Inc. | 2014 | — |
| +2 | K070845 | Sounmed Coloposcope Colpo-99/99PLUS | Sounmed, Inc. | 2007 | — |
| +2 | K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016 | — |
| +2 | K101141 | Seiler Colposcope, Models 935, 955 and 985 | Seiler Precision Microscopes | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K940094 | Colposcopes and AccessoriesSummary page 1…TIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED Leisegang Model 1D Colposcope, manufactured by Leisegang Medical, Inc., K940094 and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. K955635. Galileo Corporation 510(k) 6/3/98 Le… | 1995 |
| * | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandSummary page 1…AIMED Leisegang Model 1D Colposcope, manufactured by Leisegang Medical, Inc., K940094 and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. K955635. Galileo Corporation 510(k) 6/3/98 Leisegang Video Colposcope Page D-1 K 9195 4. DEVICE DESCRIPTION The Galile… | 1996 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.
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/K981958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981958: Leisegang Video Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981958
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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