Bistos co., Ltd.
Yongin-si Gyeonggi, KR
Bistos co., ltd. appears in FDA device records in Yongin-si Gyeonggi, KR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Bistos co., Ltd. between 2005 and 2025. The busiest year on record is 2021, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2021 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251512 | Hi bebe super (BT-150B) | HGX | Substantially Equivalent | |
| K232991 | BT-1000 | QGL | Substantially Equivalent | |
| K210289 | Infant Phototherapy Equipment | LBI | Substantially Equivalent | |
| K200675 | Hi bebe super (Models BT-150S and BT-150L) | HGX | Substantially Equivalent | |
| K160274 | Hi bebe plus | HGX | Substantially Equivalent | |
| K142799 | Model BT-220L and BT-220C | HGM | Substantially Equivalent | |
| K132543 | INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K121267 | BT-200V VASCULAR DOPPLER | HGM | Substantially Equivalent | |
| K103545 | BT-350 | HGM | Substantially Equivalent | |
| K100885 | FETAL MONITOR MODEL: BT-200T | HGM | Substantially Equivalent | |
| K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 | HGM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006179052 | 3006179052 | Bistos co., ltd. | 522, Geumeo-ro, Pogok-eup,, Yongin-si Gyeonggi 17030 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain