510(k) · Cleared
ClearedSelectcells (TM) Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Select Medical Systems, Inc. · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Mar 23, 1998 after a 90-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 23, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK974819 Selectcells (TM) MiniSelect Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK102847 Disposable Endometrial Suction CuretteJiangsu Suyun Medical Materials Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102847Disposable Endometrial Suction CuretteJiangsu Suyun Medical Materials Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974819 | Selectcells (TM) Mini | Select Medical Systems, Inc. | 1998 | — |
| +1 | K102847 | Disposable Endometrial Suction Curette | Jiangsu Suyun Medical Materials Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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 |
|---|---|---|---|
| * | — | Pipelle® Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102847 | Disposable Endometrial Suction Curette | 2011 | 0 |
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, K102847 (Jiangsu Suyun Medical Materials Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
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.
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?
Biopsy to obtain a sample for histologic evaluation of the endometrium (uterine mucosal lining) or sample extraction of the uterine menstrual content for: - Evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal cytology suggesting endometrial origin, hormonal replacement therapy (HRT); - Detection of endometrial carcinoma (Please note: The most reliable method for the detection of endometrial carcinoma is dilation…
Read the full statement (157 words)
Biopsy to obtain a sample for histologic evaluation of the endometrium (uterine mucosal lining) or sample extraction of the uterine menstrual content for:
- Evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal cytology suggesting endometrial origin, hormonal replacement therapy (HRT);
- Detection of endometrial carcinoma (Please note: The most reliable method for the detection of endometrial carcinoma is dilation of the cervix and uterine curettage performed under general anesthesia);
- Evaluation of luteal defect (Evaluation of luteal defect is visually determined histologically from endometrial tissue obtained only during the secretory [progestational] phase of the menstrual cycle);
- Endometrial dating;
- Microscopic examination;
- and, this device is useful for patients presenting a narrow cervix or cervical canal and in postmenopausal women whose cervix might be narrower with any of the indications listed above. However, because of its smaller diameter, it should be recognized that the amount (quantity) of sample obtained with this device will be reduced.
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/K974819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974819: Selectcells (TM) Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974819
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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