FDA Product Code HGX: Pump, Breast, Powered
Leading manufacturers include Shenzhen TPH Technology Co., Ltd., Shenzhen Root Innovation Technology Co., Ltd. and Medela, LLC.
239
Total
239
Cleared
166d
Avg days
1980
Since
Growing category -
54 submissions in the last 2 years
vs 31 in the prior period
Review times improving: avg
142d
recently vs 173d historically
FDA 510(k) Cleared Pump, Breast, Powered Devices (Product Code HGX)
239 devices
Cleared
Jun 04, 2026
Spectra Platinum Mini
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology
73d
Cleared
May 29, 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
Anker Innovations Limited
Obstetrics & Gynecology
149d
Cleared
May 21, 2026
Wearable Breast Pump (Model S39)
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
143d
Cleared
May 13, 2026
Electric Breast Pump (HL-3058 II Pro)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Obstetrics & Gynecology
145d
Cleared
Apr 29, 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
142d
Cleared
Apr 22, 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
Jiangxi AOV Maternity & Baby Products Co., Ltd.
Obstetrics & Gynecology
86d
Cleared
Apr 10, 2026
Freestyle Mini Hands-free
Medela, LLC
Obstetrics & Gynecology
156d
Cleared
Apr 08, 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
100d
Cleared
Apr 08, 2026
Wearable Breast Pump (Model S21A)
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)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
118d
Cleared
Apr 06, 2026
SPECTRA Wearable 2
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology
437d
Cleared
Apr 03, 2026
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Cixi Ruihong Electric Appliance Co., Ltd.
Obstetrics & Gynecology
217d
Cleared
Mar 12, 2026
Mini Moon electric breast pump (PA221)
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)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
90d
Cleared
Feb 13, 2026
Wearable Breast Pump (Model W12)
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
196d
Cleared
Feb 13, 2026
Wearable Breast Pump (Model W2)
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
196d
Cleared
Feb 13, 2026
Motion InBra (YM-8801) wearable breast pump
Medela, LLC
Obstetrics & Gynecology
141d
Cleared
Feb 06, 2026
Spectra S1 Pro
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology
274d
Cleared
Jan 22, 2026
Pump In Style® Pro+
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)
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
Obstetrics & Gynecology
91d
Cleared
Dec 19, 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
Guangdong Youmeng Electrical Technology Co., Ltd.
Obstetrics & Gynecology
144d
Cleared
Dec 19, 2025
Wearable Electric Breast Pump (YM-8803)
Guangdong Youmeng Electrical Technology Co., Ltd.
Obstetrics & Gynecology
112d
Cleared
Nov 25, 2025
Spectra Platinum
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology
154d
Cleared
Oct 29, 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
30d
About Product Code HGX - Regulatory Context
510(k) Submission Activity
239 total 510(k) submissions under product code HGX since 1980, with 239 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 54 submissions in the last 24 months compared to 31 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HGX Product Code
Recent submissions under HGX have taken an average of 142 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
HGX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →