# Okamoto USA, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 15 (1987–2026): 15 510(k) clearances
- Product codes: HIS (14), MOL (1)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)
- Mapa GmbH: 1 (https://510kreport.com/company/mapa)
- Armkel, LLC: 1 (https://510kreport.com/company/armkel)
- Mayer Laboratories: 1 (https://510kreport.com/company/mayer-laboratories)

## Firms that cite its devices most
- Suretex Limited: 1 (https://510kreport.com/company/suretex)
- Mayer Laboratories: 1 (https://510kreport.com/company/mayer-laboratories)

## Its most-cited devices
- K192669: Extremely Thin 003, ZERO ZERO THREE (2020), cited by 2
- K203541: Okamoto 002 Lubricated Polyurethane Male Condom (2022), cited by 1
- K140379: Mega Big Boy Condom (2014), cited by 1
- K090259: Okamoto Ultra Thin (2009), cited by 1
- K872812: Skinless-Skin, Pink Tint (Condom) (1987), cited by 1

## Recent decisions
- K252622: Male Latex Condom HA (May 4, 2026)
- K243584: 0.04 ZERO ZERO FOUR Male Latex Condom (Feb 18, 2025)
- K203541: Okamoto 002 Lubricated Polyurethane Male Condom (Feb 25, 2022)
- K192669: Extremely Thin 003, ZERO ZERO THREE (Jul 24, 2020)
- K141256: Okamoto Studded Condom (Jul 23, 2014)
- K140379: Mega Big Boy Condom (Jul 1, 2014)
- K090259: Okamoto Ultra Thin (Mar 31, 2009)
- K952393: Okamoto Condom (Aug 9, 1995)

Source page: https://510kreport.com/company/okamoto-usa