510(k) · Cleared
ClearedLunette Menstrual Cup, Models 1 and 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lune Group, Ltd. · HHE Cup, Menstrual
Cleared on Nov 13, 2009 as substantially equivalent to K070965 (Alicia International Pty, Ltd., 2008) and 1 other predicate after a 150-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.
- Decided
- Nov 13, 2009
- Review
- 150 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K803250 (1981). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK803250 TassawayPlastic Applications, Inc. · 1981
- 2 generations backK040335 Mooncup, Style a & BMooncup, LLC · 2005
- 1 generation backK070965 Alicia Menstrual CupAlicia International Pty, Ltd. · 2008
- This deviceK091754 Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK112165 Rhea CupApex Medical Technologies, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112165Rhea CupApex Medical Technologies, Inc. · 2012 · cites it directly0descendants
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 | K070965 | Alicia Menstrual Cup | Alicia International Pty, Ltd. | 2008 | — |
| 0 (this device) | K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K070965 | Alicia Menstrual CupSummary page 1…device: Trade or proprietary name: Lunette Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400 Predicates: AliciaTM Menstrual Cup (K070965) Mooncup Menstrual Cup (K060852) Description of the Device: The LunetteTM menstrual cup is a soft, small internally worn reusab… | 2008 |
| * | K060852 | MooncupSummary page 1…me: Lunette Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400 Predicates: AliciaTM Menstrual Cup (K070965) Mooncup Menstrual Cup (K060852) Description of the Device: The LunetteTM menstrual cup is a soft, small internally worn reusable silicone menstrual cup that h… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112165 | Rhea Cup | 2012 | 0 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K112165 (Apex Medical Technologies, Inc., 2012) has gone furthest, with 0 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. 2009, 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 Lunette Menstrual Cup (Models 1, 2) 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/K091754 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091754: Lunette Menstrual Cup, Models 1 and 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091754
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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