# K040185: Durex Studded/Ribbed Lubricated Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Ssl Americas
- Decided: Apr 27, 2004 after 91 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 K902509 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012962: Dotted Condom, Male Natural Rubber Latex Condom, Innolatex Sdn. Bhd (2001) Summary page 3.
- K902509: Saxon Ribbed Condoms, Safetex Corp. (1990) Summary page 2.
- K980319: Durex Ultra Comfort, London Intl., LLC (1998) Summary page 2.

## Most influential descendants
- K041717: Powerstick Male Latex Condoms (2005), 0 descendants of its own

## Indications for use
Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Source page: https://510kreport.com/device/K040185
Methodology: https://510kreport.com/methodology