510(k) · Cleared
ClearedSunny Cup and Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menstrual Mates · HHE Cup, Menstrual
Cleared on Jun 21, 2024 as substantially equivalent to K120107 (Sckoon, Inc., 2012) after a 266-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Jun 21, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K803250 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803250 | Tassaway | Plastic Applications, Inc. | 1981 | — |
| −2 | K040335 | Mooncup, Style a & B | Mooncup, LLC | 2005 | — |
| −1 | K120107 | Sckooncup | Sckoon, Inc. | 2012 | — |
| 0 (this device) | K233361 | Sunny Cup and Applicator | Menstrual Mates | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2002 | 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 HHE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K120107 | SckooncupSummary page 5…Page 2 of 5 3. Predicate Device Information Predicate: SckoonCup (K120107) The predicate device has not been subject to any design-related recall. 4. Device Description The Sunny Cup and Applicator is… | 2012 |
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?
- The line of descent spans 43 years and passes through 4 companies; a new generation was cleared every 11.8 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HHE devicesHHE Cup, Menstrual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Sunny Cup and Applicator 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/K233361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233361: Sunny Cup and Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233361
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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