Koken Mfg Company, Inc.: FDA clearances and approvals
Koken Mfg Company, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1986), across 3 product codes in 2 review panels. Median 510(k) review time: 25 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FQO | Table, Operating-Room, Ac-Powered | 2 | 2 |
| HME | Chair, Ophthalmic, Ac-Powered | 2 | 2 |
Plus 1 more product codes.
Review panels
Most recent Koken Mfg Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864501 | KOKEN'S NEW MODEL M-3000 POWER TABLE | — | 1986-12-16 | 32 |
| K864574 | MAC 150E OPTHALMIC CHAIR | HME | 1986-12-15 | 25 |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | HME | 1986-12-15 | 31 |
| K864325 | DR7700 OPERATING TABLE | FQO | 1986-11-19 | 16 |
| K864295 | DR.500O OPERATING TABLE | FQO | 1986-11-19 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Koken Mfg Company, 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 Koken Mfg Company, Inc. have?
Koken Mfg Company, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1986), across 3 product codes in 2 review panels.
How long does FDA take to clear Koken Mfg Company, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Koken Mfg Company, Inc.'s cleared 510(k)s is 25 days.
What devices does Koken Mfg Company, Inc. make?
Its most frequent FDA product codes are FQO (Table, Operating-Room, Ac-Powered, 2); HME (Chair, Ophthalmic, Ac-Powered, 2).
Has Koken Mfg Company, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Koken Mfg Company, Inc. Related entities may recall under other names.
Next steps
- See all 5 Koken Mfg Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FQO, Koken Mfg Company, 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.