# K233361: Sunny Cup and Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Menstrual Mates
- Decided: Jun 21, 2024 after 266 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: 3 generations back to K803250 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120107: Sckooncup, Sckoon, Inc. (2012) Summary page 5.

## Indications for use
The Sunny Cup and Applicator 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/K233361
Methodology: https://510kreport.com/methodology