510(k) · Cleared
ClearedJedmed KP6 Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jedmed Instrument Co. · HEX Colposcope (And Colpomicroscope)
Cleared on Feb 23, 1989 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 23, 1989
- Review
- 87 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK884934 Jedmed KP6 ColposcopeJedmed Instrument Co. · 1989
- Descendant · cites it directly · 4 of its ownK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- 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 ownK101141 Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010
- Descendant · 2 generations on · 0 of its ownK061306 CO-1000 Colposcope, MultipleGynex Corp. · 2006
Most influential descendants
Showing 5 of 5 · See all- K021854DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002 · cites it directly4descendants
- K070845Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007 · 2 generations on1descendant
- K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016 · 3 generations on0descendants
- K101141Seiler Colposcope, Models 935, 955 and 985Seiler Precision Microscopes · 2010 · cites it directly0descendants
- K061306CO-1000 Colposcope, MultipleGynex Corp. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884934 | Jedmed KP6 Colposcope | Jedmed Instrument Co. | 1989 | — |
| +1 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| +2 | K070845 | Sounmed Coloposcope Colpo-99/99PLUS | Sounmed, Inc. | 2007 | — |
| +3 | K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016 | — |
| +1 | K101141 | Seiler Colposcope, Models 935, 955 and 985 | Seiler Precision Microscopes | 2010 | — |
| +2 | K061306 | CO-1000 Colposcope, Multiple | Gynex Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (5)
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?
- 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/K884934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884934: Jedmed KP6 Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884934
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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