# K021356: The Divacup Menstrual Solution

- Pathway: 510(k) (Traditional)
- Applicant: Diva International, Inc.
- Decided: Jul 16, 2002 after 78 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 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.
- (no number) predicate menstrual cup: named in the summary without a submission number

## Most influential descendants
- K040335: Mooncup, Style a & B (2005), 6 descendants of its own
- K070965: Alicia Menstrual Cup (2008), 2 descendants of its own
- K120107: Sckooncup (2012), 1 descendant of its own
- K092985: Bellecup (2010), 1 descendant of its own
- K091754: Lunette Menstrual Cup, Models 1 and 2 (2009), 1 descendant of its own

## Indications for use
This menstrual cup has the same intended use as the predicate menstrual cup. The DivaCup™ is intended to be used as a receptacle, which is placed in the vagina to collect menstrual flow.

Source page: https://510kreport.com/device/K021356
Methodology: https://510kreport.com/methodology