# K112165: Rhea Cup

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Technologies, Inc.
- Decided: May 24, 2012 after 301 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: 4 generations back to K803250 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K803250: Tassaway, Plastic Applications, Inc. (1981) Summary page 1.
- K092985: Bellecup, Librette, Inc. (2010) Summary page 1.
- K091754: Lunette Menstrual Cup, Models 1 and 2, Lune Group, Ltd. (2009) Summary page 1.

## Indications for use
The Rhea 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/K112165
Methodology: https://510kreport.com/methodology