Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionet Company, 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) |
|---|---|---|---|---|---|
| K023082 | BABYCARE | Bionet Company, Ltd. | 2003-03-03 | 167 | 0 |
| K023034 | CARDIOTOUCH-3000 | Bionet Company, Ltd. | 2002-11-14 | 63 | 0 |
| K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | Bionet Company, Ltd. | 2001-11-21 | 204 | 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