# K120107: Sckooncup

- Pathway: 510(k) (Traditional)
- Applicant: Sckoon, Inc.
- Decided: Sep 18, 2012 after 249 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: 2 generations back to K803250 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040335: Mooncup, Style a & B, Mooncup, LLC (2005) Summary page 1.

## Most influential descendants
- K233361: Sunny Cup and Applicator (2024), 0 descendants of its own

## Indications for use
The SckoonCup 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/K120107
Methodology: https://510kreport.com/methodology