510(k) · Cleared
ClearedRhea Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Medical Technologies, Inc. · HHE Cup, Menstrual
Cleared on May 24, 2012 as substantially equivalent to K803250 (Plastic Applications, Inc., 1981) and 2 other predicates after a 301-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- May 24, 2012
- Review
- 301 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K803250 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK803250 TassawayPlastic Applications, Inc. · 1981
- 3 generations backK040335 Mooncup, Style a & BMooncup, LLC · 2005
- 2 generations backK070965 Alicia Menstrual CupAlicia International Pty, Ltd. · 2008
- 1 generation backK091754 Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009
- This deviceK112165 Rhea CupApex Medical Technologies, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K803250 | Tassaway | Plastic Applications, Inc. | 1981 | — |
| −3 | K040335 | Mooncup, Style a & B | Mooncup, LLC | 2005 | — |
| −2 | K070965 | Alicia Menstrual Cup | Alicia International Pty, Ltd. | 2008 | — |
| −1 | K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | 2009 | — |
| 0 (this device) | K112165 | Rhea Cup | Apex Medical Technologies, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K803250 | TassawaySummary page 1…400 Device Class: 11 Predicate Devices: Trade Name: Tassaway Trade Name: BelleCup 5 10(k) number: K803250 5 10(k) number: K092985 Product Code: HHE Product Code: HHE Tra… | 1981 |
| * | K092985 | BellecupSummary page 1…dicate Devices: Trade Name: Tassaway Trade Name: BelleCup 5 10(k) number: K803250 5 10(k) number: K092985 Product Code: HHE Product Code: HHE Trade Name: Lunette 5 10(k)… | 2010 |
| * | K091754 | Lunette Menstrual Cup, Models 1 and 2Summary page 1…10(k) number: K092985 Product Code: HHE Product Code: HHE Trade Name: Lunette 5 10(k) number: K09 1754 Product Code: HHE 5 10(k) Premarket Notification - Rhea Cup Device Descri… | 2009 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K803250.
How does its category compare?
All HHE devicesHHE Cup, Menstrual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Rhea 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/K112165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112165: Rhea Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112165
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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