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Panels › Obstetrics/Gynecology › Product code HGX · Class 2

Pump, Breast, Powered

Regulation 884.5160

38510(k)s in 12 months (254 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in HGX

Company510(k)sRecalls
Medela AG196
Shenzhen TPH Technology Co., Ltd.240
Uzinmedicare Co.120
Shenzhen Root Innovation Technology Co., Ltd.110
Evenflo Co., Inc.90
Guangdong Horigen Mother & Baby Products Co., Ltd.60
Ardo Medical AG50
Crystal Medical Products, Inc.40
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.40
Guangdong Youmeng Electrical Technology Co., Ltd.40
Decided510(k)Device and applicantCode
Oct 16, 2026K261782MODO DUO Electric Pump (B11621, B11673)
Tomy International, Inc.
HGX
Sep 17, 2026K254203Wearable Breast Pump (Model S36)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Sep 3, 2026K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural
Philips Consumer Lifestyle B.V., NL
HGX
Sep 1, 2026K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
Guangdong Horigen Mother & Baby Products Co., Ltd., CN
HGX
Aug 21, 2026K260643Cimilre Dual Max
Cimilre Co., Ltd., KR
HGX
Aug 20, 2026K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Guangdong Youmeng Electrical Technology Co., Ltd., CN
HGX
Jul 24, 2026K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Jul 13, 2026K261199Wearable Breast Pump (Model S32A)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Jun 26, 2026K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Shenzhen Changkun Technology Co., Ltd., CN
HGX
Jun 25, 2026K261025Wearable breast pump (QY-101, QY-102, QY-108)
Shenzhen Qinyi Electronic Technology Co., Ltd., CN
HGX
Jun 18, 2026K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Jun 17, 2026K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Jun 12, 2026K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Polybell (Guangzhou) Limited, CN
HGX
Jun 11, 2026K250129AViTA Breast Pump
Avita Corporation, TW
HGX
Jun 9, 2026K260864Mother's Nature W1 Warming Wearable Breast Pump
Shenzhen TPH Technology Co., Ltd., CN
HGX
Jun 4, 2026K260956Spectra Platinum Mini
Uzinmedicare Co., Ltd., KR
HGX
May 29, 2026K254300eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
Anker Innovations Limited, HK
HGX
May 21, 2026K254244Wearable Breast Pump (Model S39)
Shenzhen TPH Technology Co., Ltd., CN
HGX
May 13, 2026K254125Electric Breast Pump (HL-3058 II Pro)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., CN
HGX
Apr 29, 2026K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Apr 22, 2026K260239Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
Jiangxi AOV Maternity & Baby Products Co., Ltd., CN
HGX
Apr 10, 2026K253510Freestyle Mini Hands-free
Medela, LLC
HGX
Apr 8, 2026K260033Wearable Breast Pump (Model S21A)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Apr 8, 2026K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Apr 7, 2026K253946Momcozy 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,
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Apr 6, 2026K250208SPECTRA Wearable 2
Uzinmedicare Co., Ltd., KR
HGX
Apr 3, 2026K252744Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Cixi Ruihong Electric Appliance Co., Ltd., CN
HGX
Mar 12, 2026K252583Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
A Cute Baby, Inc.
HGX
Mar 9, 2026K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Feb 13, 2026K253149Motion InBra (YM-8801) wearable breast pump
Medela, LLC
HGX
Feb 13, 2026K252422Wearable Breast Pump (Model W2)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Feb 13, 2026K252420Wearable Breast Pump (Model W12)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Feb 6, 2026K251423Spectra S1 Pro; Spectra S2 Pro
Uzinmedicare Co., Ltd., KR
HGX
Jan 22, 2026K253498Pump In Style® Pro+
Medela, LLC
HGX
Dec 23, 2025K253072Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd., CN
HGX
Dec 19, 2025K252754Wearable Electric Breast Pump (YM-8803)
Guangdong Youmeng Electrical Technology Co., Ltd., CN
HGX
Dec 19, 2025K252342Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
Guangdong Youmeng Electrical Technology Co., Ltd., CN
HGX
Nov 25, 2025K251932Spectra Platinum
Uzinmedicare Co., Ltd., KR
HGX
Oct 29, 2025K253283Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Oct 27, 2025K252630Electric Breast Pump (HL-3060, F5113)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., CN
HGX
Oct 27, 2025K252629Electric Breast Pump (HL-3058, F5112)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., CN
HGX
Oct 22, 2025K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
Ningbo Youhe Electrical Appliance Technology Co., Ltd., CN
HGX
Sep 25, 2025K251512Hi bebe super (BT-150B)
Bistos Co., Ltd., KR
HGX
Sep 18, 2025K251377Magic InBra
Medela AG, CH
HGX
Sep 8, 2025K251754Wearable Breast Pump (Model S33)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Sep 8, 2025K251394Momcozy Wearable Breast Pump (BP223)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Aug 20, 2025K250383Wearable Breast Pump (Model W6)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Aug 13, 2025K252192Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
Huizhou Lvb Maternal and Infant Supplies Co., Ltd., CN
HGX
Aug 11, 2025K250207eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
Anker Innovations Limited, CN
HGX
Jul 31, 2025K250843Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)
Shenzhen TPH Technology Co., Ltd., CN
HGX

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