510(k) · Cleared
Recalled · Class II · 2019Berkeley V-10 Vacuum Curettage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · HHI System, Abortion, Vacuum
Cleared on Jun 23, 2003 as substantially equivalent to K813282 (Synemed, Inc., 1981) after a 90-day review. Its family tree reaches back 1 generation to 1981. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- HHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813282 (1981). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK813282 Synevac Vacuum Curettage SystemsSynemed, Inc. · 1981
- This deviceK030935 Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003
- Descendant · cites it directly · 2 of its ownK093508 Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global · 2010
- Descendant · 2 generations on · 1 of its ownK140213 Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK251882 Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi) · 2025
- Descendant · 3 generations on · 0 of its ownK172151 Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK171440 Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K093508Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global · 2010 · cites it directly2descendants
- K140213Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd. · 2015 · 2 generations on1descendant
- K251882Uterine Aspiration SetGcmedica Enterprise Ltd.(Wuxi) · 2025 · cites it directly0descendants
- K172151Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018 · 3 generations on0descendants
- K171440Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813282 | Synevac Vacuum Curettage Systems | Synemed, Inc. | 1981 | — |
| 0 (this device) | K030935 | Berkeley V-10 Vacuum Curettage System | Acmi Corporation | 2003 | — |
| +1 | K093508 | Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12) | Womancare Global | 2010 | — |
| +2 | K140213 | Disposable Endoscopic Cannula | Dongguan Microview Medical Technology Co., Ltd. | 2015 | — |
| +1 | K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | 2025 | — |
| +3 | K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018 | — |
| +1 | K171440 | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 HHI? 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? (2)
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 |
|---|---|---|---|
| * | K813282 | Synevac Vacuum Curettage SystemsSummary page 1…Berkeley@ VC-2 Vacuum Curettage System (Preamendment) Synevac @Vacuum Curettage System 10 (K8 13282) D. Device Description 1. Intended Use… | 1981 |
| * | — | Berkeley VC-2 Vacuum Curettage System Named without a submission number |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2019 | Class II | Z-0159-2020 | Process control | Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HHI devicesHHI System, Abortion, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HHI
Too few HHI 510(k)s in any year since 2007 to give a median.
Recalls per year · HHI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHI
3in 2024
MAUDE reports naming product code HHI, 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 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For rapid transcervical aspiration of the uterine cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030935 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030935: Berkeley V-10 Vacuum Curettage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030935
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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