510(k) · Cleared
ClearedTassaway
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastic Applications, Inc. · HHE Cup, Menstrual
Cleared on Feb 12, 1981 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 12, 1981
- Review
- 51 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK803250 TassawayPlastic Applications, Inc. · 1981
- Descendant · cites it directly · 6 of its ownK040335 Mooncup, Style a & BMooncup, LLC · 2005
- Descendant · 2 generations on · 2 of its ownK070965 Alicia Menstrual CupAlicia International Pty, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK120107 SckooncupSckoon, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK092985 BellecupLibrette, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK091754 Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040335Mooncup, Style a & BMooncup, LLC · 2005 · cites it directly6descendants
- K070965Alicia Menstrual CupAlicia International Pty, Ltd. · 2008 · 2 generations on2descendants
- K120107SckooncupSckoon, Inc. · 2012 · 2 generations on1descendant
- K092985BellecupLibrette, Inc. · 2010 · 2 generations on1descendant
- K091754Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K803250 | Tassaway | Plastic Applications, Inc. | 1981 | — |
| +1 | K040335 | Mooncup, Style a & B | Mooncup, LLC | 2005 | — |
| +2 | K070965 | Alicia Menstrual Cup | Alicia International Pty, Ltd. | 2008 | — |
| +2 | K120107 | Sckooncup | Sckoon, Inc. | 2012 | — |
| +2 | K092985 | Bellecup | Librette, Inc. | 2010 | — |
| +3 | K091754 | Lunette Menstrual Cup, Models 1 and 2 | Lune Group, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K040335 (Mooncup, LLC, 2005) has gone furthest, with 6 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.
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 | — |
https://510kreport.com/device/K803250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K803250: Tassaway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K803250
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026