510(k) · Cleared
ClearedCervical MD, Model C10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sti Medical Systems · HEX Colposcope (And Colpomicroscope)
Cleared on Jan 31, 2008 as substantially equivalent to K955635 (Welch Allyn, Inc., 1996) after a 129-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Jan 31, 2008
- Review
- 129 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955635 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK955635 Video Colposcope/Vertical Rolling Base/Swing Arm StandWelch Allyn, Inc. · 1996
- This deviceK072691 Cervical MD, Model C10Sti Medical Systems · 2008
- Descendant · cites it directly · 1 of its ownK090324 Ultrasight HD Digital Colposcopy with Imagesense TechnologySti Medical Systems · 2010
- Descendant · 2 generations on · 0 of its ownK110147 Ultrasighthd C31 with Imagesense and Remote Viewer TelemedicineSti Medical Systems, LLC · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm Stand | Welch Allyn, Inc. | 1996 | — |
| 0 (this device) | K072691 | Cervical MD, Model C10 | Sti Medical Systems | 2008 | — |
| +1 | K090324 | Ultrasight HD Digital Colposcopy with Imagesense Technology | Sti Medical Systems | 2010 | — |
| +2 | K110147 | Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine | Sti Medical Systems, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandSummary page 1…Class II Product Code: HEX Advisory Panel: Obstetrics/Gynecology Predicate Device: Welch Allen Video Colposcope Model 88000 (K955635) Device Description: CervicalMD is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090324 | Ultrasight HD Digital Colposcopy with Imagesense Technology | 2010 | 1 |
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. 2008, 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?
Cervical MDTM is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072691 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072691: Cervical MD, Model C10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072691
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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