510(k) Report

510(k) · Cleared

Cleared

Mooncup, Style a & B

K040335510(k) TraditionalCleared Mar 30, 2005413-day reviewClass II21 CFR 884.5400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mooncup, LLC · HHE Cup, Menstrual

Cleared on Mar 30, 2005 as substantially equivalent to K021356 (Diva International, Inc., 2002) and 2 other predicates after a 413-day review. Its family tree reaches back 1 generation to 1981. 6 later devices descend from it.

Decided
Mar 30, 2005
Review
413 days
Class
Class II
Product code
HHE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K803250 (1981). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1987: 1 other ancestor2012: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2009: 1 descendant cleared2024: 1 descendant clearedK803250 · Tassaway · Plastic Applications, Inc. · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants K803250 · Tassaway · Plastic Applications, Inc. · 19810
  1. Root · 1 generation backK803250 TassawayPlastic Applications, Inc. · 1981
  2. This deviceK040335 Mooncup, Style a & BMooncup, LLC · 2005
  3. Descendant · cites it directly · 2 of its ownK070965 Alicia Menstrual CupAlicia International Pty, Ltd. · 2008
  4. Descendant · cites it directly · 1 of its ownK120107 SckooncupSckoon, Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK092985 BellecupLibrette, Inc. · 2010
  6. Descendant · 2 generations on · 1 of its ownK091754 Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009
  7. Descendant · 2 generations on · 0 of its ownK233361 Sunny Cup and ApplicatorMenstrual Mates · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12012: 22024: 1
2008high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K070965Alicia Menstrual CupAlicia International Pty, Ltd. · 2008 · cites it directly2descendants
  • K120107SckooncupSckoon, Inc. · 2012 · cites it directly1descendant
  • K092985BellecupLibrette, Inc. · 2010 · cites it directly1descendant
  • K091754Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd. · 2009 · 2 generations on1descendant
  • K233361Sunny Cup and ApplicatorMenstrual Mates · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K803250TassawayPlastic Applications, Inc.1981—
0 (this device)K040335Mooncup, Style a & BMooncup, LLC2005—
+1K070965Alicia Menstrual CupAlicia International Pty, Ltd.2008—
+1K120107SckooncupSckoon, Inc.2012—
+1K092985BellecupLibrette, Inc.2010—
+2K091754Lunette Menstrual Cup, Models 1 and 2Lune Group, Ltd.2009—
+2K233361Sunny Cup and ApplicatorMenstrual Mates2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201220
202410
FIG. 1 — Lineage of K040335, 1981–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233361 Sunny Cup and Applicatorscore 8.2 · 3 generations · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K021356The Divacup Menstrual Solution
Summary page 1
…roprietary name: MoonCup® Common or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400 Predicates: DivaCupTM- Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250) Description of the Device: General. The MoonCup® menstrual cu…
Diva International, Inc.2002—
*K870803The Keeper
Summary page 1
…ommon or usual name: Menstrual Cup Classification name of the device: 21 CFR §884.5400 Predicates: DivaCupTM- Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250) Description of the Device: General. The MoonCup® menstrual cup is a soft, small internally wor…
The Keeper Co.1987—
*K803250Tassaway
Summary page 1
…Cup Classification name of the device: 21 CFR §884.5400 Predicates: DivaCupTM- Menstrual Solution (K021356) The Keeper® (K870803) Tassaway (K803250) Description of the Device: General. The MoonCup® menstrual cup is a soft, small internally worn reusable silicone menstru…
Plastic Applications, Inc.1981—

Also cleared against K021356: 1 other device →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070965Alicia Menstrual CupAlicia International Pty, Ltd.20082
K120107SckooncupSckoon, Inc.20121
K092985BellecupLibrette, Inc.20101

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K070965 (Alicia International Pty, Ltd., 2008) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K021356.

How does its category compare?

All HHE devices

HHE Cup, Menstrual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHE

1in 2024

2008: 12009: 12010: 12012: 32014: 12024: 1
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHE

249in 2012

2012: 249 days median
2007high 249 (2012)2026

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

2008: 12009: 12010: 12012: 22014: 22015: 22016: 12017: 42018: 12019: 222020: 2202021: 402022: 262023: 1332024: 292025: 34
2007high 220 (2020) · low 0 (2007)2025

MAUDE reports naming product code HHE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—01
20091—01
20101—01
20110—00
2012324902
20130—00
20141—02
20150—02
20160—01
20170—04
20180—01
20190—022
20200—0220
20210—040
20220—026
20230—0133
20241—029
20250—034
20260—0—

What is it indicated for?

The MoonCup® 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.

Also cleared against K021356

1 other device cites the same predicate.

  • K140626Meluna Classic/Sport Menstrual CupMeluna · 2014

Recent decisions in HHE

The HHE category page

  • K233361Sunny Cup and ApplicatorMenstrual Mates · 2024
  • K140626Meluna Classic/Sport Menstrual CupMeluna · 2014
  • K121857FemmycycleFemcap Incorporated · 2012
  • K120107SckooncupSckoon, Inc. · 2012
  • K112165Rhea CupApex Medical Technologies, Inc. · 2012

https://510kreport.com/device/K040335 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040335: Mooncup, Style a & B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040335

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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