Okamoto USA, Inc.: FDA clearances and approvals
Okamoto USA, Inc. has 15 FDA 510(k) clearances (first 1987, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 90 days. Since 2017 its median was 280 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 104 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 303 |
| 2021 | 0 | — |
| 2022 | 1 | 449 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 1 | 258 |
Review time against the same product codes
Since 2017, Okamoto USA, Inc.'s cleared 510(k)s took a median 280 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 14 | 14 |
| MOL | Condom, Synthetic | 1 | 1 |
Review panels
Most recent Okamoto USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252622 | Male Latex Condom HA | HIS | 2026-05-04 | 258 |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | HIS | 2025-02-18 | 90 |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | MOL | 2022-02-25 | 449 |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | HIS | 2020-07-24 | 303 |
| K141256 | OKAMOTO STUDDED CONDOM | HIS | 2014-07-23 | 70 |
| K140379 | MEGA BIG BOY CONDOM | HIS | 2014-07-01 | 137 |
| K090259 | OKAMOTO ULTRA THIN | HIS | 2009-03-31 | 57 |
| K952393 | OKAMOTO CONDOM | HIS | 1995-08-09 | 79 |
| K902804 | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT | HIS | 1990-08-13 | 47 |
| K896339 | MODIFIED LABELING ON OKAMOTO HARMONY CONDOM | HIS | 1990-01-10 | 68 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Okamoto USA, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Okamoto USA, Inc. have?
Okamoto USA, Inc. has 15 FDA 510(k) clearances (first 1987, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Okamoto USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Okamoto USA, Inc.'s cleared 510(k)s is 90 days. Since 2017: 280 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Okamoto USA, Inc. make?
Its most frequent FDA product codes are HIS (Condom, 14); MOL (Condom, Synthetic, 1).
Has Okamoto USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Okamoto USA, Inc. Related entities may recall under other names.
Next steps
- See all 15 Okamoto USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Okamoto USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.