Cleared Special

Hi bebe super (Models BT-150S and BT-150L)

K200675 · Bistos Co., Ltd. · Obstetrics & Gynecology
Feb 2021
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K200675 is an FDA 510(k) clearance for the Hi bebe super (Models BT-150S and BT-150L), 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 February 10, 2021, 331 days after receiving the submission on March 16, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K200675 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2020
Decision Date February 10, 2021
Days to Decision 331 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

Similar Devices — HGX Pump, Breast, Powered

All 226
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
K252583 · A Cute Baby, Inc. · Mar 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
K253934 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2026
Wearable Breast Pump (Model W12)
K252420 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Wearable Breast Pump (Model W2)
K252422 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Motion InBra (YM-8801) wearable breast pump
K253149 · Medela, LLC · Feb 2026
Spectra S1 Pro; Spectra S2 Pro
K251423 · Uzinmedicare Co., Ltd. · Feb 2026