Clearance Summary
Hi bebe super (BT-150B) received FDA 510(k) clearance under submission number K251512, sponsored by Bistos Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-09-25.
- Submission: K251512
- Applicant / Sponsor: Bistos Co., Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2025-09-25
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.