510(k) · Cleared
ClearedColposcope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuzhou Kernel Medical Equipment Co., Ltd. · HEX Colposcope (And Colpomicroscope)
Cleared on Sep 14, 2016 as substantially equivalent to K021153 (Goldway Us, Inc., 2003) and 2 other predicates after a 219-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 14, 2016
- Review
- 219 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K940094 (1995). 19 ancestors in all, the oldest K760763 (1976). No later device cites it as a predicate yet.
- Root · 4 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 3 generations backK981958 Leisegang Video ColposcopeNetoptix Corp. · 1998
- 2 generations backK021854 DFV CPG ColposcopeD.F. Vasconcellos S.A. · 2002
- 1 generation backK070845 Sounmed Coloposcope Colpo-99/99PLUSSounmed, Inc. · 2007
- This deviceK160341 Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −3 | K981958 | Leisegang Video Colposcope | Netoptix Corp. | 1998 | — |
| −2 | K021854 | DFV CPG Colposcope | D.F. Vasconcellos S.A. | 2002 | — |
| −1 | K070845 | Sounmed Coloposcope Colpo-99/99PLUS | Sounmed, Inc. | 2007 | — |
| 0 (this device) | K160341 | Colposcope System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 2 | 0 |
| 1977 | 2 | 0 |
| 1985 | 2 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Summary page 4…on Number: 21CFR 884.1630 Review Panel: Obstetrics/Gynecology 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K021153 Product Name: Goldway SLC-2000 Digital Video Colposcope Imaging System Model Name: SLC-2000A Predicat… | 2003 |
| * | K070845 | Sounmed Coloposcope Colpo-99/99PLUSSummary page 4…21153 Product Name: Goldway SLC-2000 Digital Video Colposcope Imaging System Model Name: SLC-2000A Predicate Device 2 510(k) Number: K070845 Product Name: Colposcope COLPO-99/99 Plus Model Name: COLPO-99 Plus… | 2007 |
| * | K140754 | Cooper Surgical Leisegang Colposcope SystemSummary page 5…Page 2 of 5 Predicate Device 3 510(k) Number: K140754 Product Name: Leisegang Colposcope Systems Model Name: 3ML 6. Device Description The Colposcope System is inten… | 2014 |
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- None of the 19 ancestors has a recall.
- 4 other devices also cite its predicate K021153.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160341: Colposcope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160341
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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