510(k) · Cleared
ClearedHysteroscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongquin Jinshan Science & Technology (Group) Co., Ltd. · HGH Cannula, Suction, Uterine
Cleared on Apr 9, 2018 as substantially equivalent to K140213 (Dongguan Microview Medical Technology Co., Ltd., 2015) after a 266-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Apr 9, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- HGH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K813282 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK813282 Synevac Vacuum Curettage SystemsSynemed, Inc. · 1981
- 3 generations backK030935 Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003 · Recalled
- 2 generations backK093508 Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global · 2010
- 1 generation backK140213 Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd. · 2015
- This deviceK172151 Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K813282 | Synevac Vacuum Curettage Systems | Synemed, Inc. | 1981 | — |
| −3 | K030935 | Berkeley V-10 Vacuum Curettage System | Acmi Corporation | 2003 | 1 |
| −2 | K093508 | Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12) | Womancare Global | 2010 | — |
| −1 | K140213 | Disposable Endoscopic Cannula | Dongguan Microview Medical Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018 | — |
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 HGH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K140213 | Disposable Endoscopic CannulaSummary page 4…DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD. Trade Name: Disposable Endoscopic Cannula FDA 510(k) #: K140213 The predicate device has not been subject to a design related recall. 5. Description of the Device [21 CFR 807.92(a)(4)] ==… | 2015 |
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 37 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All HGH devicesHGH Cannula, Suction, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HGH
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HGH
Too few HGH 510(k)s in any year since 2007 to give a median.
Recalls per year · HGH
No recall names HGH since 2007.
Adverse event reports per year · HGH
1in 2024
MAUDE reports naming product code HGH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172151: Hysteroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172151
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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