Bistos Co., Ltd.: FDA clearances and approvals
Bistos Co., Ltd. has 11 FDA 510(k) clearances (first 2005, latest 2025), across 5 product codes in 3 review panels. Median 510(k) review time: 162 days. Since 2017 its median was 232 days, against 156 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 98 |
| 2013 | 0 | — |
| 2014 | 1 | 324 |
| 2015 | 1 | 283 |
| 2016 | 1 | 212 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 223 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 341 |
| 2025 | 1 | 132 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bistos Co., Ltd.'s cleared 510(k)s took a median 232 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 5 | 5 |
| HGX | Pump, Breast, Powered | 3 | 3 |
| FMZ | Incubator, Neonatal | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
| QGL | Transcutaneous Nerve Stimulator For Adhd | 1 | 1 |
Review panels
Most recent Bistos Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251512 | Hi bebe super (BT-150B) | HGX | 2025-09-25 | 132 |
| K232991 | BT-1000 | QGL | 2024-08-28 | 341 |
| K210289 | Infant Phototherapy Equipment | LBI | 2021-05-28 | 115 |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | HGX | 2021-02-10 | 331 |
| K160274 | Hi bebe plus | HGX | 2016-09-01 | 212 |
| K142799 | Model BT-220L and BT-220C | HGM | 2015-07-09 | 283 |
| K132543 | INFANT INCUBATOR | FMZ | 2014-07-03 | 324 |
| K121267 | BT-200V VASCULAR DOPPLER | HGM | 2012-08-02 | 98 |
| K103545 | BT-350 | HGM | 2011-05-13 | 162 |
| K100885 | FETAL MONITOR MODEL: BT-200T | HGM | 2010-06-07 | 69 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bistos 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 Bistos Co., Ltd. have?
Bistos Co., Ltd. has 11 FDA 510(k) clearances (first 2005, latest 2025), across 5 product codes in 3 review panels.
How long does FDA take to clear Bistos Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bistos Co., Ltd.'s cleared 510(k)s is 162 days. Since 2017: 232 days, versus 156 days for all cleared 510(k)s in the same product codes.
What devices does Bistos Co., Ltd. make?
Its most frequent FDA product codes are HGM (System, Monitoring, Perinatal, 5); HGX (Pump, Breast, Powered, 3); FMZ (Incubator, Neonatal, 1).
Has Bistos Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bistos Co., Ltd. Related entities may recall under other names.
Next steps
- See all 11 Bistos Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Bistos 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.