# K203541: Okamoto 002 Lubricated Polyurethane Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Okamoto USA, Inc.
- Decided: Feb 25, 2022 after 449 days
- Product code: MOL (Condom, Synthetic)
- 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 K100767 (2011). 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)
- K100767: Trojan Supra Lubricated Polyurethane Male Condom, Church & Dwight Co., Inc. (2011) Summary page 4.

## Most influential descendants
- K252158: Sagami Original 002 Polyurethane Male Condom (2026), 0 descendants of its own

## Indications for use
The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Source page: https://510kreport.com/device/K203541
Methodology: https://510kreport.com/methodology