# K980174: Durex Colors and Scents

- Pathway: 510(k) (Traditional)
- Applicant: London Intl., LLC
- Decided: Aug 13, 1998 after 205 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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.

## Most influential descendants
- K131866: Sustain (2014), 0 descendants of its own
- K052959: Durex Male Colored Latex Condoms with Scented Lubricants (2006), 0 descendants of its own

## Indications for use
A latex rubber condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and the spread of sexually transmitted diseases.

Source page: https://510kreport.com/device/K980174
Methodology: https://510kreport.com/methodology