Company ยท US
Okamoto USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2026 | K252622 | Male Latex Condom HA Okamoto USA, Inc. | HIS |
| Feb 18, 2025 | K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom Okamoto USA, Inc. | HIS |
| Feb 25, 2022 | K203541 | Okamoto 002 Lubricated Polyurethane Male Condom Okamoto USA, Inc. | MOL |
| Jul 24, 2020 | K192669 | Extremely Thin 003, ZERO ZERO THREE Okamoto USA, Inc. | HIS |
| Jul 23, 2014 | K141256 | OKAMOTO STUDDED CONDOM Okamoto USA, Inc. | HIS |
| Jul 1, 2014 | K140379 | MEGA BIG BOY CONDOM Okamoto USA, Inc. | HIS |
| Mar 31, 2009 | K090259 | OKAMOTO ULTRA THIN Okamoto USA, Inc. | HIS |
| Aug 9, 1995 | K952393 | OKAMOTO CONDOM Okamoto USA, Inc. | HIS |
| Aug 13, 1990 | K902804 | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT Okamoto USA, Inc. | HIS |
| Jan 10, 1990 | K896339 | MODIFIED LABELING ON OKAMOTO HARMONY CONDOM Okamoto USA, Inc. | HIS |
| Mar 10, 1989 | K884402 | EXTRA STRENGTH SKIN LESS SKIN CONDOM Okamoto USA, Inc. | HIS |
| Jan 12, 1989 | K884401 | SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT Okamoto USA, Inc. | HIS |
| Feb 26, 1988 | K875111 | RUBBER CONTRACEPTIVE, LATEX CONDOMS Okamoto USA, Inc. | HIS |
| Nov 5, 1987 | K872812 | SKINLESS-SKIN, PINK TINT (CONDOM) Okamoto USA, Inc. | HIS |
| Nov 5, 1987 | K872664 | SKINLESS SKIN-HARMONY CONDOMS Okamoto USA, Inc. | HIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||