510(k) · Cleared
ClearedMas with or Without Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marina Medical Instruments, Inc. · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Apr 8, 2003 as substantially equivalent to K915491 (Bioteque Corp., 1992) after a 305-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Apr 8, 2003
- Review
- 305 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915491 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915491 CurelleBioteque Corp. · 1992
- This deviceK021876 Mas with or Without SyringeMarina Medical Instruments, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK192534 CrossBay Endometrial Tissue Sampler (ETS)Crossbay Medical · 2020
- Descendant · 2 generations on · 0 of its ownK201952 CrossGlide ETS PlusCrossbay Medical · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915491 | Curelle | Bioteque Corp. | 1992 | — |
| 0 (this device) | K021876 | Mas with or Without Syringe | Marina Medical Instruments, Inc. | 2003 | — |
| +1 | K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | 2020 | — |
| +2 | K201952 | CrossGlide ETS Plus | Crossbay Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K915491 | CurelleSummary page 2…tantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. FDA file reference number 510k915491 Attachments inside notification Appendix 1 and 2 CHARACTERISTICS Compatibility with environment and other devic… | 1992 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | 2020 | 1 |
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.
- Of its descendants, K192534 (Crossbay Medical, 2020) has gone furthest, with 1 descendant 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?
This device is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy or for menstrual extraction
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/K021876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021876: Mas with or Without Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021876
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