510(k) · Cleared
ClearedMediscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sometech Corporation · HEX Colposcope (And Colpomicroscope)
Cleared on Dec 19, 2003 as substantially equivalent to K955635 (Welch Allyn, Inc., 1996) after a 227-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 19, 2003
- Review
- 227 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955635 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955635 Video Colposcope/Vertical Rolling Base/Swing Arm StandWelch Allyn, Inc. · 1996
- This deviceK031436 MediscopeSometech Corporation · 2003
View 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) | K031436 | Mediscope | Sometech Corporation | 2003 | — |
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 2…SUBSTANTIAL EQUIVALENCE: SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALLY EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM ( 510 (K) NUMBER K955635 ). MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be use… | 1996 |
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?
- Its one ancestor has no recall.
- 7 other devices also cite its predicate K955635.
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?
MEDISCOPE, colposcope (Obstetrical and Gynecological Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031436: Mediscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031436
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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