Cleared Special

Hi bebe super (BT-150B)

K251512 · Bistos Co., Ltd. · Obstetrics & Gynecology
Sep 2025
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K251512 is an FDA 510(k) clearance for the Hi bebe super (BT-150B), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Bistos Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 25, 2025, 132 days after receiving the submission on May 16, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K251512 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2025
Decision Date September 25, 2025
Days to Decision 132 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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