510(k) · Cleared
ClearedIntermed Zoom Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermed Group, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Aug 22, 2003 as substantially equivalent to K913365 (Vineland Medical Products, Inc., 1992) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K853389 (1985). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK853389 Wallach Zoom ColposcopeWallach Surgical Devices, Inc. · 1985
- This deviceK031639 Intermed Zoom ColposcopeIntermed Group, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK132423 The GynocularGynius AB · 2014
- Descendant · cites it directly · 0 of its ownK073053 Colpo-MasterUnited Products & Instruments, Inc. · 2007
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 | K853389 | Wallach Zoom Colposcope | Wallach Surgical Devices, Inc. | 1985 | — |
| 0 (this device) | K031639 | Intermed Zoom Colposcope | Intermed Group, Inc. | 2003 | — |
| +1 | K132423 | The Gynocular | Gynius AB | 2014 | — |
| +1 | K073053 | Colpo-Master | United Products & Instruments, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K913365 | Accuscope (TM) & Accuscope II (TM)Summary page 1…aimed Device Manufacturer 5 1O(K) Accuscope Vineland Medical Products K913365 Wallach Zoom Colposcope Wallach Surgical Devices K853389 LMlZ Zoom Scope Leisegang M… | 1992 |
| * | K853389 | Wallach Zoom ColposcopeSummary page 1…1O(K) Accuscope Vineland Medical Products K913365 Wallach Zoom Colposcope Wallach Surgical Devices K853389 LMlZ Zoom Scope Leisegang Medical K9023 13 4. Device Description The… | 1985 |
| * | K902313 | LM-1Z Zoom ScopeSummary page 1…K913365 Wallach Zoom Colposcope Wallach Surgical Devices K853389 LMlZ Zoom Scope Leisegang Medical K9023 13 4. Device Description The Intermed Zoom Colposcope consists of a stereo zoom microscope mounted to a mo… | 1990 |
What descends from it? (2)
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K132423 (Gynius AB, 2014) has gone furthest, with 0 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 | — |
What is it indicated for?
The Intermed Zoom Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031639: Intermed Zoom Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031639
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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