Home / 510(k) Clearances / K160274

510(k) K160274

Hi bebe plus by Bistos Co., Ltd. — Product Code HGX

K160274 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "Hi bebe plus". The FDA issued a decision of Substantially Equivalent on September 1, 2016. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2016
Date Received
February 2, 2016
Clearance Type
Traditional
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.

  • K251512 — Hi bebe super (BT-150B) (September 25, 2025)
  • 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)
  • 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

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)

FDA data resources