Ok Biotech Co., Ltd.: FDA clearances and approvals
Ok Biotech Co., Ltd. has 9 FDA 510(k) clearances (first 2007, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time: 313 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 357 |
| 2015 | 2 | 360 |
| 2016 | 2 | 258 |
| 2017 | 1 | 141 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 380 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ok Biotech Co., Ltd.'s cleared 510(k)s took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 9 | 9 |
Review panels
Most recent Ok Biotech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | NBW | 2022-10-07 | 380 |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | NBW | 2017-01-19 | 141 |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | NBW | 2016-07-29 | 204 |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | NBW | 2016-07-20 | 313 |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | NBW | 2015-12-17 | 447 |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2015-04-15 | 274 |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-08-14 | 357 |
| K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2010-02-04 | 335 |
| K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2007-02-09 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Ok Biotech Co., Ltd..
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 Ok Biotech Co., Ltd. have?
Ok Biotech Co., Ltd. has 9 FDA 510(k) clearances (first 2007, latest 2022), across 1 product code in 1 review panel.
How long does FDA take to clear Ok Biotech Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ok Biotech Co., Ltd.'s cleared 510(k)s is 313 days.
What devices does Ok Biotech Co., Ltd. make?
Its most frequent FDA product codes are NBW (System, Test, Blood Glucose, Over The Counter, 9).
Has Ok Biotech Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ok Biotech Co., Ltd. Related entities may recall under other names.
Next steps
- See all 9 Ok Biotech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Ok Biotech Co., Ltd.'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.