510(k) · Cleared
ClearedSeiler Colposcope, Models 935, 955 and 985
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seiler Precision Microscopes · HEX Colposcope (And Colpomicroscope)
Cleared on Aug 6, 2010 as substantially equivalent to K021854 (D.F. Vasconcellos S.A., 2002) and 2 other predicates after a 106-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 6, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
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 deviceK101141 Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010
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) | 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 |
|---|---|---|
| 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? (3)
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 2…lassification Number: 21 CFR 884.1630 Regulation Name: Colposcope Class II Product Code: HEX Company Name 510(k) Number D.F. Vasconcellos K021854 Jedmed Inst. Co K884934 Leisegang K940094 '5* DEPARTMENT OF HEALTH & HUMAN… | 2002 |
| * | K884934 | Jedmed KP6 ColposcopeSummary page 2…Regulation Name: Colposcope Class II Product Code: HEX Company Name 510(k) Number D.F. Vasconcellos K021854 Jedmed Inst. Co K884934 Leisegang K940094 '5* DEPARTMENT OF HEALTH & HUMAN SERVICES.… | 1989 |
| * | K940094 | Colposcopes and AccessoriesSummary page 2…roduct Code: HEX Company Name 510(k) Number D.F. Vasconcellos K021854 Jedmed Inst. Co K884934 Leisegang K940094 '5* DEPARTMENT OF HEALTH & HUMAN SERVICES.… | 1995 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.0 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. 2010, this device’s year, is highlighted.
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 Seiler colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101141: Seiler Colposcope, Models 935, 955 and 985.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101141
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