# K001212: Trojan Extra Large Latex Condom

- Pathway: 510(k) (Special)
- Applicant: Armkel, LLC
- Decided: May 9, 2000 after 25 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.
4 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K140379: Mega Big Boy Condom (2014), 1 descendant of its own
- K243584: 0.04 ZERO ZERO FOUR Male Latex Condom (2025), 0 descendants of its own
- K081265: Thai Nippon Male Latex Condom (2009), 0 descendants of its own
- K072747: Unidus Magnum Male Latex Condom (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K001212
Methodology: https://510kreport.com/methodology