510(k) · Cleared
ClearedRELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li Medical Corporation, Ltd. · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Sep 25, 2024 as substantially equivalent to K092982 (Panpac Medical Corporation, 2010) after a 224-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Sep 25, 2024
- Review
- 224 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092982 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK092982 The Panpac Suction CurettePanpac Medical Corporation · 2010
- This deviceK240434 RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)Li Medical Corporation, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092982 | The Panpac Suction Curette | Panpac Medical Corporation | 2010 | — |
| 0 (this device) | K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | Li Medical Corporation, Ltd. | 2024 | — |
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 K251882 Uterine Aspiration Setscore 10.5 · 2 generations · 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 |
|---|---|---|---|
| * | K092982 | The Panpac Suction CuretteSummary page 6…EDICATE DEVICES REFERENCED IN THE SUBMISSION Predicate Device： The PANPAC SUCTION CURETTE Company Name： PANPAC 510(k) number: K092982 The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The “RELIEEV” Suction Cure… | 2010 |
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?
- Its one ancestor has no recall.
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. 2024, 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?
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and
from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of
biopsy precancer screening or they can be used for menstrual extraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240434: RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240434
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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