510(k) · Cleared
ClearedThe Divacup Menstrual Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diva International, Inc. · HHE Cup, Menstrual
Cleared on Jul 16, 2002 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 78 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK021356 The Divacup Menstrual SolutionDiva International, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK040335 Mooncup, Style a & BMooncup, LLC · 2005
- Descendant · 2 generations on · 2 of its ownK070965 Alicia Menstrual CupAlicia International Pty, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK120107 SckooncupSckoon, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK092985 BellecupLibrette, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK091754 Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K040335Mooncup, Style a & BMooncup, LLC · 2005 · cites it directly6descendants
- K070965Alicia Menstrual CupAlicia International Pty, Ltd. · 2008 · 2 generations on2descendants
- K120107SckooncupSckoon, Inc. · 2012 · 2 generations on1descendant
- K092985BellecupLibrette, Inc. · 2010 · 2 generations on1descendant
- K091754Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021356 | The Divacup Menstrual Solution | Diva International, Inc. | 2002 | — |
| +1 | K040335 | Mooncup, Style a & B | Mooncup, LLC | 2005 | — |
| +2 | K070965 | Alicia Menstrual Cup | Alicia International Pty, Ltd. | 2008 | — |
| +2 | K120107 | Sckooncup | Sckoon, Inc. | 2012 | — |
| +2 | K092985 | Bellecup | Librette, Inc. | 2010 | — |
| +3 | K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HHE? 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 HHE device
- #1 K233361 Sunny Cup and Applicatorscore 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | predicate menstrual cup Named without a submission number |
What descends from it? (8)
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, K040335 (Mooncup, LLC, 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HHE devicesHHE Cup, Menstrual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HHE
249in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HHE
No recall names HHE since 2007.
Adverse event reports per year · HHE
34in 2025
MAUDE reports naming product code HHE, 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 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | 249 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 0 | — | 0 | 220 |
| 2021 | 0 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 0 | — | 0 | 133 |
| 2024 | 1 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This menstrual cup has the same intended use as the predicate menstrual cup. The DivaCup™ is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021356: The Divacup Menstrual Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021356
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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