# K023176: Undus Male Latex Condom (with Flavoring)

- Pathway: 510(k) (Abbreviated)
- Applicant: Unidus Corp.
- Decided: Dec 13, 2002 after 81 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
Longest line of descent: 1 generation back to K993403 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993403: Remed Male Tutti Frutti Condom (Strawberry) Preventor, Lucky Boy, Summit, Remed Pharma (2000) Summary page 1.

## Indications for use
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Source page: https://510kreport.com/device/K023176
Methodology: https://510kreport.com/methodology