Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Bistos with 11 510(k) clearances. The most recent is a 510(k) clearance dated Sep 25, 2025: Hi bebe super (BT-150B).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 25, 2025 | Hi bebe super (BT-150B)K251512 · HGX | 510(k) clearances |
| Aug 28, 2024 | BT-1000K232991 · QGL | 510(k) clearances |
| May 28, 2021 | Infant Phototherapy EquipmentK210289 · LBI | 510(k) clearances |
| Feb 10, 2021 | Hi bebe super (Models BT-150S and BT-150L)K200675 · HGX | 510(k) clearances |
| Sep 1, 2016 | Hi bebe plusK160274 · HGX | 510(k) clearances |
| Jul 9, 2015 | Model BT-220L and BT-220CK142799 · HGM | 510(k) clearances |
| Jul 3, 2014 | INFANT INCUBATORK132543 · FMZ | 510(k) clearances |
| Aug 2, 2012 | BT-200V VASCULAR DOPPLERK121267 · HGM | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
