# K243584: 0.04 ZERO ZERO FOUR Male Latex Condom

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: Feb 18, 2025 after 90 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: 2 generations back to K001212 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140379: Mega Big Boy Condom, Okamoto USA, Inc. (2014) Summary page 5.

## Indications for use
0.04 Zero Zero Four Male Latex 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/K243584
Methodology: https://510kreport.com/methodology