Cleared Special

K251512 - Hi bebe super (BT-150B) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251512 · Bistos Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
132d
Days
Class 2
Risk

K251512 is an FDA 510(k) clearance for the Hi bebe super (BT-150B). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Bistos Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 25, 2025 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bistos Co., Ltd. devices

Submission Details

510(k) Number K251512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 160d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 234
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K251512.
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