# K031007: Kwikeze Male Condom Applicator

- Pathway: 510(k) (Abbreviated)
- Applicant: Condax, LLC
- Decided: Nov 14, 2003 after 228 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 K874383 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K874383: Mentor Plus (Condom), Arcon Corp. (1988) Summary page 1.

## Most influential descendants
- K052206: Zeus Male Condom Applicator (2006), 0 descendants of its own

## Indications for use
The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The 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/K031007
Methodology: https://510kreport.com/methodology