FDA Product Code HGX: Pump, Breast, Powered
Leading manufacturers include Shenzhen TPH Technology Co., Ltd., Shenzhen Root Innovation Technology Co., Ltd. and Medela, Inc..
250
Total
250
Cleared
168d
Avg days
1980
Since
Growing category -
61 submissions in the last 2 years
vs 34 in the prior period
Consistent review times:
150d avg (recent)
FDA 510(k) Cleared Pump, Breast, Powered Devices (Product Code HGX)
250 devices
Cleared
Aug 21, 2026
Cimilre Dual Max
Cimilre Co., Ltd.
Obstetrics & Gynecology
175d
Cleared
Aug 20, 2026
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Guangdong Youmeng Electrical Technology Co., Ltd.
Obstetrics & Gynecology
122d
Cleared
Jul 24, 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
177d
Cleared
Jul 13, 2026
Wearable Breast Pump (Model S32A)
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
91d
Cleared
Jun 26, 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology
532d
Cleared
Jun 25, 2026
Wearable breast pump (QY-101, QY-102, QY-108)
Shenzhen Qinyi Electronic Technology Co., Ltd.
Obstetrics & Gynecology
87d
Cleared
Jun 18, 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
171d
Cleared
Jun 17, 2026
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology
120d
Cleared
Jun 12, 2026
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Polybell (Guangzhou) Limited
Obstetrics & Gynecology
129d
Cleared
Jun 11, 2026
AViTA Breast Pump
Avita Corporation
Obstetrics & Gynecology
510d
Cleared
Jun 09, 2026
Mother's Nature W1 Warming Wearable Breast Pump
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology
84d
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
About Product Code HGX - Regulatory Context
510(k) Submission Activity
250 total 510(k) submissions under product code HGX since 1980, with 250 receiving FDA clearance (average review time: 168 days).
Submission volume has increased in recent years - 61 submissions in the last 24 months compared to 34 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HGX Product Code
FDA review times for HGX submissions have been consistent, averaging 150 days recently vs 173 days historically.
HGX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →