Okamoto U.S.A., Inc.
Stratford, CT, US
OKAMOTO U.S.A., INC. appears in FDA device records in Stratford, CT. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Okamoto U.S.A., Inc. between 1987 and 2026. The busiest year on record is 1987, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1995 | 1 |
| 2009 | 1 |
| 2014 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252622 | Male Latex Condom HA | HIS | Substantially Equivalent | |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | HIS | Substantially Equivalent | |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | MOL | Substantially Equivalent | |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | HIS | Substantially Equivalent | |
| K141256 | OKAMOTO STUDDED CONDOM | HIS | Substantially Equivalent | |
| K140379 | MEGA BIG BOY CONDOM | HIS | Substantially Equivalent | |
| K090259 | OKAMOTO ULTRA THIN | HIS | Substantially Equivalent | |
| K952393 | OKAMOTO CONDOM | HIS | Substantially Equivalent | |
| K902804 | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT | HIS | Substantially Equivalent | |
| K896339 | MODIFIED LABELING ON OKAMOTO HARMONY CONDOM | HIS | Substantially Equivalent | |
| K884402 | EXTRA STRENGTH SKIN LESS SKIN CONDOM | HIS | Substantially Equivalent | |
| K884401 | SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT | HIS | Substantially Equivalent | |
| K875111 | RUBBER CONTRACEPTIVE, LATEX CONDOMS | HIS | Substantially Equivalent | |
| K872812 | SKINLESS-SKIN, PINK TINT (CONDOM) | HIS | Substantially Equivalent | |
| K872664 | SKINLESS SKIN-HARMONY CONDOMS | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431332 | 2431332 | OKAMOTO U.S.A., INC. | 18 KING ST., Stratford, CT 06615 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain