510(k) · Cleared
Recalled · Class II · 2022Berkeley VC-10 Vacuum Curettage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi · HHI System, Abortion, Vacuum
Cleared on Sep 29, 2017 as substantially equivalent to K030935 (Acmi Corporation, 2003) after a 136-day review. Its family tree reaches back 2 generations to 1981. It has been recalled once.
- Decided
- Sep 29, 2017
- Review
- 136 days
- Class
- Class II
- Product code
- HHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813282 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K030935 | Berkeley V-10 Vacuum Curettage SystemSummary page 4…Berkeley VC-10 Vacuum Curettage System Generic/Common Name: Vacuum abortion system Predicate Device K030935 Gyrus ACMI VC-10 The predicate device has not been subject to a design-related recall. Pro… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2022 | Class II | Z-0078-2023 | Labeling design | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K030935.
How does its category compare?
All HHI devicesHHI System, Abortion, Vacuum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171440: Berkeley VC-10 Vacuum Curettage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171440
Report an extraction error
Are you the manufacturer?
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