Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionet Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
352 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 | 238 | 0 |
| K231150 | Cardio P1 | Bionet Co., Ltd. | 2023-11-09 | 202 | 0 |
| K220535 | Cardio10 | Bionet Co., Ltd. | 2022-11-15 | 264 | 0 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5C | Bionet Co., Ltd. | 2022-10-11 | 264 | 0 |
| K130322 | SPM-300 | Bionet Co., Ltd. | 2013-11-15 | 280 | 0 |
| K113306 | CARDIO 7 | Bionet Co., Ltd. | 2012-07-16 | 250 | 0 |
| K102767 | CARDIO XP | Bionet Co., Ltd. | 2011-06-03 | 252 | 0 |
| K090895 | EKG-PLUS II SOFTWARE | Bionet Co., Ltd. | 2009-08-26 | 149 | 0 |
| K082008 | BIONET BM3PLUS PATIENT MONITOR | Bionet Co., Ltd. | 2008-12-11 | 149 | 0 |
| K043597 | FC 700 FETAL MONITOR | Bionet Co., Ltd. | 2005-12-16 | 352 | 0 |
| K043598 | FC 1400 FETAL MONITOR | Bionet Co., Ltd. | 2005-12-16 | 352 | 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