510(k) · Cleared
ClearedSynevac Vacuum Curettage Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synemed, Inc. · HHI System, Abortion, Vacuum
Cleared on Dec 14, 1981 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 14, 1981
- Review
- 27 days
- Class
- Class II
- Product code
- HHI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK813282 Synevac Vacuum Curettage SystemsSynemed, Inc. · 1981
- Descendant · cites it directly · 5 of its ownK030935 Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003 · Recalled
- 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 · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030935Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003 · cites it directly5descendants
- 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 · 2 generations on0descendants
- K172151Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813282 | Synevac Vacuum Curettage Systems | Synemed, Inc. | 1981 | — |
| +1 | K030935 | Berkeley V-10 Vacuum Curettage System | Acmi Corporation | 2003 | 1 |
| +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 | — |
| +2 | K251882 | Uterine Aspiration Set | Gcmedica Enterprise Ltd.(Wuxi) | 2025 | — |
| +3 | K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K030935 (Acmi Corporation, 2003) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K813282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K813282: Synevac Vacuum Curettage Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K813282
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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