# K141256: Okamoto Studded Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: Jul 23, 2014 after 70 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: 6 generations back to K952415 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111093: Billy Boy Male Latex Condom, Mapa GmbH (2011) Summary page 1.

## Indications for use
The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K141256
Methodology: https://510kreport.com/methodology