# K040335: Mooncup, Style a & B

- Pathway: 510(k) (Traditional)
- Applicant: Mooncup, LLC
- Decided: Mar 30, 2005 after 413 days
- Product code: HHE (Cup, Menstrual)
- Device class: 2
- Regulation: 21 CFR 884.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K803250 (1981). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021356: The Divacup Menstrual Solution, Diva International, Inc. (2002) Summary page 1.
- K870803: The Keeper, The Keeper Co. (1987) Summary page 1.
- K803250: Tassaway, Plastic Applications, Inc. (1981) Summary page 1.

## Most influential descendants
- K070965: Alicia Menstrual Cup (2008), 2 descendants of its own
- K120107: Sckooncup (2012), 1 descendant of its own
- K092985: Bellecup (2010), 1 descendant of its own
- K091754: Lunette Menstrual Cup, Models 1 and 2 (2009), 1 descendant of its own
- K233361: Sunny Cup and Applicator (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K040335
Methodology: https://510kreport.com/methodology