Chrysalis Intelligence · Sponsors · Okamoto USA, Inc.

Okamoto USA, Inc.

Stratford, CT, US · 4 510(k) clearances

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Total clearances

4

2020-07-24 → 2026-05-04

Last 12 months

1

Product codes

2

Most recent

2026-05-04

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
HIS	Condom	Class II	Obstetrics/Gynecology	3	2026-05-04
MOL	Condom, Synthetic	Class II	Obstetrics/Gynecology	1	2022-02-25

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2026-05-04	K252622	Male Latex Condom HA	HIS	Class II	Obstetrics/Gynecology
2025-02-18	K243584	0.04 ZERO ZERO FOUR Male Latex Condom	HIS	Class II	Obstetrics/Gynecology
2022-02-25	K203541	Okamoto 002 Lubricated Polyurethane Male Condom	MOL	Class II	Obstetrics/Gynecology
2020-07-24	K192669	Extremely Thin 003, ZERO ZERO THREE	HIS	Class II	Obstetrics/Gynecology