510(k) · Cleared
ClearedUterine Aspiration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gcmedica Enterprise Ltd.(Wuxi) · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Oct 16, 2025 as substantially equivalent to K030935 (Acmi Corporation, 2003) after a 118-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Oct 16, 2025
- Review
- 118 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- 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 HHK? 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 HHK device
- #1 K240434 RELIEEV Suction Curette (Flexible 3.0/…score 8.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 6…Uterine Aspiration Tubing Set. 5.3 Predicate Device Berkeley® VC-10 Vacuum Curettage System, Berkeley® Vacurette® Cannulas and Cannulas(F-tips), Collection Tubing Set, K030935 The predicate device experienced one recall event due to a manufacturing process control issue. However, the recall was not rela… | 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)
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 44 years and passes through 3 companies; a new generation was cleared every 22.3 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 HHK devicesHHK Curette, Suction, Endometrial (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HHK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHK
Too few HHK 510(k)s in any year since 2007 to give a median.
Recalls per year · HHK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHK
9in 2025
MAUDE reports naming product code HHK, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Uterine Aspiration Set is used with the vacuum system to aspirate transcervically the products of conception or menstruation from the uterus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251882 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251882: Uterine Aspiration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251882
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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