FDA 510(k)

Hi bebe super (BT-150B)

K-Number: K251512 · 2025-09-25

Decision Date2025-09-25

Product CodeHGX

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Hi bebe super (BT-150B) is a medical device manufactured by Bistos Co., Ltd.. It received FDA 510(k) clearance on 2025-09-25 under approval number K251512. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hi bebe super (BT-150B)?

Hi bebe super (BT-150B) is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Bistos Co., Ltd.. The 510(k) number is K251512.

When was Hi bebe super (BT-150B) approved by the FDA?

Hi bebe super (BT-150B) received FDA 510(k) clearance on 2025-09-25, under approval number K251512.

What company makes Hi bebe super (BT-150B)?

Hi bebe super (BT-150B) is manufactured by Bistos Co., Ltd..

What is the FDA product code for Hi bebe super (BT-150B)?

The FDA product code for Hi bebe super (BT-150B) is HGX.

Other Devices by Bistos Co., Ltd.

K160274Hi bebe plus K210289Infant Phototherapy Equipment K200675Hi bebe super (Models BT-150S and BT-150L) K232991BT-1000

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.