# K140305: Caya Contoured Diaphragm

- Pathway: 510(k) (Traditional)
- Applicant: Kessel Medintim GmbH
- Decided: Aug 26, 2014 after 200 days
- Product code: HDW (Diaphragm, Contraceptive (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.5350
- 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 K063223 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080040: Ortho All-Flex Diaphragm, Johnson & Johnson Produtos Profissionais Ltda. (2008) Summary page 4.

## Indications for use
The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.

Source page: https://510kreport.com/device/K140305
Methodology: https://510kreport.com/methodology