510(k) · Cleared
ClearedMooncup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mooncup Limited · HHE Cup, Menstrual
Cleared on Dec 26, 2006 after a 273-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 26, 2006
- Review
- 273 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
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 |
|---|---|---|---|---|---|
| 0 (this device) | K060852 | Mooncup | Mooncup Limited | 2006 | — |
| +1 | K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | 2009 | — |
| +2 | K112165 | Rhea Cup | Apex Medical Technologies, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K091754 | Lunette Menstrual Cup, Models 1 and 2 | 2009 | 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?
- Of its descendants, K091754 (Lune Group, Ltd., 2009) has gone furthest, with 1 descendant 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?
The Mooncup 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 510(k) statement.
https://510kreport.com/device/K060852 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060852: Mooncup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060852
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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