510(k) · Cleared
ClearedMeluna Classic/Sport Menstrual Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jul 10, 2014 as substantially equivalent to K021356 (Diva International, Inc., 2002) after a 121-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jul 10, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021356 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021356 The Divacup Menstrual SolutionDiva International, Inc. · 2002
- This deviceK140626 Meluna Classic/Sport Menstrual CupMeluna · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021356 | The Divacup Menstrual Solution | Diva International, Inc. | 2002 | — |
| 0 (this device) | K140626 | Meluna Classic/Sport Menstrual Cup | Meluna | 2014 | — |
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 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 8.1 · 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 |
|---|---|---|---|
| * | K021356 | The Divacup Menstrual SolutionSummary page 1…ny Product 510(k) # Diva International, Inc. Diva Cup K021356 DEVICE DESCRIPTION The Meluna Menstrual Cup isa soft small TPE (Thermoplastic elastomer) menstrual cup that is placed internally… | 2002 |
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.
- 1 other device also cites its predicate K021356.
How does its category compare?
All HHE devicesHHE Cup, Menstrual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The Metuna Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140626: Meluna Classic/Sport Menstrual Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140626
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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