Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ok Biotech Co., Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
313 daysmedian FDA review time
447 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022-10-07 | 380 | 0 |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2017-01-19 | 141 | 0 |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2016-07-29 | 204 | 0 |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO | Ok Biotech Co., Ltd. | 2016-07-20 | 313 | 0 |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2015-12-17 | 447 | 0 |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2015-04-15 | 274 | 0 |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2014-08-14 | 357 | 0 |
| K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2010-02-04 | 335 | 0 |
| K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | Ok Biotech Co., Ltd. | 2007-02-09 | 130 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda