ClearanceBrief
510(k) K251512 ยท HGX Pump, Breast, Powered

Hi bebe super (BT-150B)

ApplicantBistos Co., Ltd., Seongnam-Si, KR
DecisionSubstantially Equivalent, Sep 25, 2025
ReceivedMay 16, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K251512

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.