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510(k) K251512

Hi bebe super (BT-150B) by Bistos Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2025
Date Received
May 16, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Bistos Co., Ltd.

  • K232991 — BT-1000 (August 28, 2024)
  • K210289 — Infant Phototherapy Equipment (May 28, 2021)
  • K200675 — Hi bebe super (Models BT-150S and BT-150L) (February 10, 2021)
  • K160274 — Hi bebe plus (September 1, 2016)
  • K142799 — Model BT-220L and BT-220C (July 9, 2015)
  • K132543 — INFANT INCUBATOR (July 3, 2014)
  • K121267 — BT-200V VASCULAR DOPPLER (August 2, 2012)
  • K103545 — BT-350 (May 13, 2011)
  • K100885 — FETAL MONITOR MODEL: BT-200T (June 7, 2010)
  • K052190 — FETAL MONITOR, MODELS BT-300 AND BT-200 (October 4, 2005)

Other clearances for product code HGX

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  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)