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.

248
Total
248
Cleared
168d
Avg days
1980
Since
Growing category - 61 submissions in the last 2 years vs 32 in the prior period
Consistent review times: 154d avg (recent)

FDA 510(k) Cleared Pump, Breast, Powered Devices (Product Code HGX)

248 devices
1–24 of 248
Cleared Jun 04, 2026
Spectra Platinum Mini
K260956
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)
K254300
Anker Innovations Limited
Obstetrics & Gynecology · 149d
Cleared May 21, 2026
Wearable Breast Pump (Model S39)
K254244
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 143d
Cleared May 13, 2026
Electric Breast Pump (HL-3058 II Pro)
K254125
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)
K253914
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 142d
Cleared Apr 22, 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239
Jiangxi AOV Maternity & Baby Products Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared Apr 10, 2026
Freestyle Mini Hands-free
K253510
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)
K254258
Shenzhen Root Innovation Technology Co., Ltd.
Obstetrics & Gynecology · 100d
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

About Product Code HGX - Regulatory Context

510(k) Submission Activity

248 total 510(k) submissions under product code HGX since 1980, with 248 receiving FDA clearance (average review time: 168 days).

Submission volume has increased in recent years - 61 submissions in the last 24 months compared to 32 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 154 days recently vs 172 days historically.

HGX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →