Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Osang Healthcare Co. , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203562 | Finetest Lite Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2021-07-13 | 218 | 0 |
| K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2020-10-16 | 141 | 0 |
| K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co. , Ltd. | 2018-09-19 | 27 | 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