# K980319: Durex Ultra Comfort

- Pathway: 510(k) (Traditional)
- Applicant: London Intl., LLC
- Decided: May 20, 1998 after 113 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.
7 later devices descend from it; 5 cite it directly.
0 of 8 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
- K042957: Durex Male Latex Condom with Warming Lubricant (2005), 1 descendant of its own
- K040185: Durex Studded/Ribbed Lubricated Latex Condom (2004), 1 descendant of its own
- K131866: Sustain (2014), 0 descendants of its own
- K072169: Durex Synthetic Polyisoprene Male Condom (2008), 0 descendants of its own
- K051273: Divas Dual Pleasure Male Latex Condom (2005), 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 spread of sexually transmitted diseases.

Source page: https://510kreport.com/device/K980319
Methodology: https://510kreport.com/methodology