# K140379: Mega Big Boy Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: Jul 1, 2014 after 137 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 K001212 (2000). 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)
- K001212: Trojan Extra Large Latex Condom, Armkel, LLC (2000) Summary page 1.

## Most influential descendants
- K243584: 0.04 ZERO ZERO FOUR Male Latex Condom (2025), 0 descendants of its own

## Indications for use
Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/AIDS and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K140379
Methodology: https://510kreport.com/methodology