HGX · Class II · 21 CFR 884.5160

FDA Product Code HGX: Pump, Breast, Powered

Leading manufacturers include Shenzhen TPH Technology Co., Ltd., Shenzhen Root Innovation Technology Co., Ltd. and Medela, LLC.

255
Total
255
Cleared
167d
Avg days
1980
Since
255 devices
25–48 of 255
Cleared Apr 08, 2026
Wearable Breast Pump (Model S21A)
K260033
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 92d
Cleared Apr 07, 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
K253946
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 118d
Cleared Apr 06, 2026
SPECTRA Wearable 2
K250208
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 437d
Cleared Apr 03, 2026
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
K252744
Cixi Ruihong Electric Appliance Co., Ltd.
Obstetrics & Gynecology · 217d
Cleared Mar 12, 2026
Mini Moon electric breast pump (PA221)
K252583
A Cute Baby, Inc.
Obstetrics & Gynecology · 209d
Cleared Mar 09, 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.
Obstetrics & Gynecology · 90d
Cleared Feb 13, 2026
Wearable Breast Pump (Model W12)
K252420
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Feb 13, 2026
Wearable Breast Pump (Model W2)
K252422
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Feb 13, 2026
Motion InBra (YM-8801) wearable breast pump
K253149
Medela, LLC
Obstetrics & Gynecology · 141d
Cleared Feb 06, 2026
Spectra S1 Pro
K251423
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 274d
Cleared Jan 22, 2026
Pump In Style® Pro+
K253498
Medela, LLC
Obstetrics & Gynecology · 85d
Cleared Dec 23, 2025
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
K253072
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Dec 19, 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
K252342
Guangdong Youmeng Electrical Technology Co., Ltd.
Obstetrics & Gynecology · 144d
Cleared Dec 19, 2025
Wearable Electric Breast Pump (YM-8803)
K252754
Guangdong Youmeng Electrical Technology Co., Ltd.
Obstetrics & Gynecology · 112d
Cleared Nov 25, 2025
Spectra Platinum
K251932
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Oct 29, 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
K253283
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 30d
Cleared Oct 27, 2025
Electric Breast Pump (HL-3058, F5112)
K252629
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Obstetrics & Gynecology · 68d
Cleared Oct 27, 2025
Electric Breast Pump (HL-3060, F5113)
K252630
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Obstetrics & Gynecology · 68d
Cleared Oct 22, 2025
electric breast pump (FZ-P8)
K251977
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Obstetrics & Gynecology · 117d
Cleared Sep 25, 2025
Hi bebe super (BT-150B)
K251512
Bistos Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Sep 18, 2025
Magic InBra
K251377
Medela AG
Obstetrics & Gynecology · 139d
Cleared Sep 08, 2025
Momcozy Wearable Breast Pump (BP223)
K251394
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 126d
Cleared Sep 08, 2025
Wearable Breast Pump (Model S33)
K251754
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Aug 20, 2025
Wearable Breast Pump (Model W6)
K250383
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 190d