510(k) · Cleared
ClearedSckooncup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sckoon, Inc. · HHE Cup, Menstrual
Cleared on Sep 18, 2012 as substantially equivalent to K040335 (Mooncup, LLC, 2005) after a 249-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Sep 18, 2012
- Review
- 249 days
- Class
- Class II
- Product code
- HHE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K803250 (1981). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K233361Sunny Cup and ApplicatorMenstrual Mates · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803250 | Tassaway | Plastic Applications, Inc. | 1981 | — |
| −1 | K040335 | Mooncup, Style a & B | Mooncup, LLC | 2005 | — |
| 0 (this device) | K120107 | Sckooncup | Sckoon, Inc. | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K040335 | Mooncup, Style a & BSummary page 1…Review Panel: Obstetrics/Gynecology Regulation Number 21 CFR 884.5400 Product Code: HHE Device Class: II Predicate Device: MoonCup (K0403 35) Predicate Device Information: MoonCup Mooncup LLC One East Main Street, Madison, WI 53701 5 10(k) Number: K040335 Device Descr… | 2005 |
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 |
|---|---|---|---|
| K233361 | Sunny Cup and Applicator | 2024 | 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 31 years and passes through 3 companies; a new generation was cleared every 24.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233361 (Menstrual Mates, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040335.
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 SckoonCup 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/K120107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120107: Sckooncup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120107
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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