# K021186: Condomi Nature, Condomi Stimulation, Condomi Vanilla Gold, Condomi Supersafe, Condomi XXL, Condomi Strong,

- Pathway: 510(k) (Traditional)
- Applicant: Condomi Erfert Prodoktionsgesellschaft Mbh
- Decided: Oct 25, 2002 after 193 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Condomi brand latex condoms are intended to be used as a contraceptive (for the prevention of pregnancy) and/or for the prevention of the transmission of sexually transmitted diseases.

Source page: https://510kreport.com/device/K021186
Methodology: https://510kreport.com/methodology