Bionet Co., Ltd.: FDA clearances and approvals
Bionet Co., Ltd. has 11 FDA 510(k) clearances (first 2005, latest 2023), across 6 product codes in 4 review panels. Median 510(k) review time: 252 days. Since 2017 its median was 251 days, against 118 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 250 |
| 2013 | 1 | 280 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 264 |
| 2023 | 2 | 220 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bionet Co., Ltd.'s cleared 510(k)s took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| LOS | 1 | 1 | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (6)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- Radiology (1)
Most recent Bionet Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231160 | Cardio Q50, Cardio Q70 | DPS | 2023-12-15 | 238 |
| K231150 | Cardio P1 | DPS | 2023-11-09 | 202 |
| K220535 | Cardio10 | DPS | 2022-11-15 | 264 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | IYN | 2022-10-11 | 264 |
| K130322 | SPM-300 | BZG | 2013-11-15 | 280 |
| K113306 | CARDIO 7 | DPS | 2012-07-16 | 250 |
| K102767 | CARDIO XP | DPS | 2011-06-03 | 252 |
| K090895 | EKG-PLUS II SOFTWARE | LOS | 2009-08-26 | 149 |
| K082008 | BIONET BM3PLUS PATIENT MONITOR | MWI | 2008-12-11 | 149 |
| K043598 | FC 1400 FETAL MONITOR | HGM | 2005-12-16 | 352 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bionet 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 Bionet Co., Ltd. have?
Bionet Co., Ltd. has 11 FDA 510(k) clearances (first 2005, latest 2023), across 6 product codes in 4 review panels.
How long does FDA take to clear Bionet Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bionet Co., Ltd.'s cleared 510(k)s is 252 days. Since 2017: 251 days, versus 118 days for all cleared 510(k)s in the same product codes.
What devices does Bionet Co., Ltd. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 5); HGM (System, Monitoring, Perinatal, 2); BZG (Spirometer, Diagnostic, 1).
Has Bionet Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bionet Co., Ltd. Related entities may recall under other names.
Next steps
- See all 11 Bionet Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Bionet 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.