Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Okamoto USA, Inc. — Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

303 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K252622	Male Latex Condom HA	Okamoto USA, Inc.	2026-05-04	258
K243584	0.04 ZERO ZERO FOUR Male Latex Condom	Okamoto USA, Inc.	2025-02-18	90
K203541	Okamoto 002 Lubricated Polyurethane Male Condom	Okamoto USA, Inc.	2022-02-25	449
K192669	Extremely Thin 003, ZERO ZERO THREE	Okamoto USA, Inc.	2020-07-24	303
K141256	OKAMOTO STUDDED CONDOM	Okamoto USA, Inc.	2014-07-23	70
K140379	MEGA BIG BOY CONDOM	Okamoto USA, Inc.	2014-07-01	137
K090259	OKAMOTO ULTRA THIN	Okamoto USA, Inc.	2009-03-31	57
K952393	OKAMOTO CONDOM	Okamoto USA, Inc.	1995-08-09	79
K902804	EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT	Okamoto USA, Inc.	1990-08-13	47
K896339	MODIFIED LABELING ON OKAMOTO HARMONY CONDOM	Okamoto USA, Inc.	1990-01-10	68
K884402	EXTRA STRENGTH SKIN LESS SKIN CONDOM	Okamoto USA, Inc.	1989-03-10	142
K884401	SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT	Okamoto USA, Inc.	1989-01-12	85
K875111	RUBBER CONTRACEPTIVE, LATEX CONDOMS	Okamoto USA, Inc.	1988-02-26	74
K872812	SKINLESS-SKIN, PINK TINT (CONDOM)	Okamoto USA, Inc.	1987-11-05	112
K872664	SKINLESS SKIN-HARMONY CONDOMS	Okamoto USA, Inc.	1987-11-05	120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda