510(k) · Cleared
ClearedWallach Zoom Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Nov 19, 1985 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 19, 1985
- Review
- 98 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK853389 Wallach Zoom ColposcopeWallach Surgical Devices, Inc. · 1985
- Descendant · cites it directly · 4 of its ownK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- Descendant · cites it directly · 2 of its ownK031639 Intermed Zoom ColposcopeIntermed Group, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK070845 Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK160341 Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK132423 The GynocularGynius AB · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021854DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002 · cites it directly4descendants
- K031639Intermed Zoom ColposcopeIntermed Group, Inc. · 2003 · cites it directly2descendants
- K070845Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007 · 2 generations on1descendant
- K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016 · 3 generations on0descendants
- K132423The GynocularGynius AB · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853389 | Wallach Zoom Colposcope | Wallach Surgical Devices, Inc. | 1985 | — |
| +1 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| +1 | K031639 | Intermed Zoom Colposcope | Intermed Group, Inc. | 2003 | — |
| +2 | K070845 | Sounmed Coloposcope Colpo-99/99PLUS | Sounmed, Inc. | 2007 | — |
| +3 | K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016 | — |
| +1 | K132423 | The Gynocular | Gynius AB | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
4 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?
- Of its descendants, K021854 (D.F. Vasconcellos S.A., 2002) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K853389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K853389: Wallach 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/K853389
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026