# K060852: Mooncup

- Pathway: 510(k) (Traditional)
- Applicant: Mooncup Limited
- Decided: Dec 26, 2006 after 273 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091754: Lunette Menstrual Cup, Models 1 and 2 (2009), 1 descendant of its own
- K112165: Rhea Cup (2012), 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/K060852
Methodology: https://510kreport.com/methodology