# K140626: Meluna Classic/Sport Menstrual Cup

- Pathway: 510(k) (Traditional)
- Applicant: Meluna
- Decided: Jul 10, 2014 after 121 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 K021356 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Metuna Menstrual Cup 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/K140626
Methodology: https://510kreport.com/methodology