# K111093: Billy Boy Male Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Mapa GmbH
- Decided: Jun 3, 2011 after 45 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: 5 generations back to K952415 (1996). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103119: Billy Boy Male Latex Condom, Sheila Pickering PHD (2011) Summary page 1.
- K011253: Flavored Male Latex Condom, Thai Nippon Rubber Industry Co., Ltd. (2001) Summary page 4.
- K871304: Lifestyles Extra Strength Condoms W/Nonoxynol-9, Ansell, Inc. (1987) Summary page 1.

## Most influential descendants
- K141256: Okamoto Studded Condom (2014), 0 descendants of its own

## Indications for use
The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.

Source page: https://510kreport.com/device/K111093
Methodology: https://510kreport.com/methodology