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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
Jul 15, 2025K250350Thrive 2-in-1 Breast Pump (Model P3)
Shenzhen TPH Technology Co., Ltd., CN
HGX
May 30, 2025K250368Wearable Breast Pump (Model S21)
Shenzhen TPH Technology Co., Ltd., CN
HGX
May 30, 2025K250365Motif Aura Glow breast pump (Model Motif Aura Glow)
Shenzhen TPH Technology Co., Ltd., CN
HGX
May 30, 2025K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
Ningbo Youhe Electrical Appliance Technology Co., Ltd., CN
HGX
Apr 21, 2025K243508Wearable breast pump (model S12A)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Apr 17, 2025K250829Lacevo Wearable Breast Pump (Model S70)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Apr 2, 2025K250152eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breas
Shenzhen TPH Technology Co., Ltd., CN
HGX
Mar 20, 2025K250463Ameda GLO Wearable Breast Pump (Model W8S)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Feb 21, 2025K242850Wearable breast pump (model W8)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Feb 6, 2025K242111VIVACE
Unimom.Co, KR
HGX
Dec 20, 2024K243629Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcoz
Shenzhen Root Innovation Technology Co., , Ltd., CN
HGX
Dec 20, 2024K241680Momcozy Wearable Breast Pump (BP311)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Dec 19, 2024K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
Joytech Healthcare Co. , Ltd., CN
HGX
Oct 17, 2024K240218Electric Breast Pump (F5055)
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., CN
HGX
Sep 27, 2024K242125Elvie Stride 2
Chiaro Technology, Ltd., GB
HGX
Sep 11, 2024K241004Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, A
Huizhou Lvb Maternal and Infant Supplies Co., Ltd., CN
HGX
Aug 30, 2024K231969BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
Dongguanshi Yiyingmei Technology Co., Ltd., CN
HGX
Jul 12, 2024K241705MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (ste
Milkmate Products, Inc.
HGX
Jul 1, 2024K240536Wearable Breast Pump (Model S32)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Jun 27, 2024K241506Annabella Double Breast Pump (ADO-US23-1000)
Annabella Tech, IL
HGX
Jun 6, 2024K232774Wearable Breast Pump,Model S18
Ningbo Dearevery Electronic Technology Co., Ltd., CN
HGX
May 14, 2024K233913Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BR
Aoj Health Technology Co., Ltd., CN
HGX
May 9, 2024K232477Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
Jiangxi AOV Maternity & Baby Products Co., Ltd., CN
HGX
Apr 12, 2024K232608Duo Hands-free Breast Pump
Medela, LLC
HGX
Mar 28, 2024K232047VIVACE
Unimom.Co, KR
HGX
Mar 13, 2024K233136Hygeia Express Powered Breast Pump
Hygeia II Medical Group, Inc.
HGX
Mar 6, 2024K233880Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
Shenzhen Root Innovation Technology Co., Ltd., CN
HGX
Jan 26, 2024K231785Perifit Pump
X6 Innovations, FR
HGX
Jan 19, 2024K232466Electric Breast Pump, model: YM-8166
Guangdong Youmeng Electrical Technology Co., Ltd., CN
HGX
Nov 3, 2023K230481Evenflo Premium Double Electric Breast Pump (Model 4018)
Evenflo Feeding, Inc.
HGX
Oct 26, 2023K231595Electric Breast Pump
Shenzhen Changkun Technology Co., Ltd., CN
HGX
Oct 16, 2023K230570Willow Generation 3 Breast Pump
Willow Innovations, Inc.
HGX
Sep 21, 2023K230102Smart double sides wearable breast pump, Electric bilateral breast pump
Huizhou Lvb Maternal and Infant Supplies Co., Ltd., CN
HGX
Aug 4, 2023K230672Annabella Breast Pump
Annabella , Ltd., IL
HGX
Jul 14, 2023K223886Wearable Breast Pump (Model S18)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Jun 30, 2023K230469Compact Wearable Pump
Lansinoh Laboratories
HGX
Jun 9, 2023K230776Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
Shenzhen Lutejiacheng Technology Co., Ltd., CN
HGX
May 26, 2023K223329Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
Guangzhou Yongyi Industrial Co., Ltd., CN
HGX
Mar 30, 2023K230590ARDO Bellis
Ardo Medical AG, CH
HGX
Mar 16, 2023K223084MilkMate Breast Pump
Milkmate Products, Inc.
HGX
Mar 9, 2023K223693Electric breast pump (model: M5)
Shenzhen Lutejiacheng Technology Co., Ltd., CN
HGX
Mar 3, 2023K222573imani i2Plus Breast Pump
Imani Co., CN
HGX
Jan 13, 2023K222782Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
Zhejiang Carebao Co., Ltd., CN
HGX
Jan 4, 2023K222045Wearable Breast Pump (Model S1DW)
Shenzhen TPH Technology Co., Ltd., CN
HGX
Dec 23, 2022K222726Smartpump 3.0 Double Electric Breast Pump
Lansinoh Laboratories
HGX
Dec 23, 2022K221708CIMILRE Free-T2 Plus
Cimilre Co., Ltd., KR
HGX
Dec 12, 2022K220926Spectra Wearable
Uzinmedicare Co., Ltd., KR
HGX
Dec 9, 2022K221598Wearable breast pump
Mayborn (Uk) Limited, GB
HGX
Oct 12, 2022K221576Ameda Pearl Electric Breast Pump
Ameda, Inc.
HGX
Jun 29, 2022K211016Powered Breast Pump (Models 7V and 7X)
Haenim Co., Ltd., KR
HGX

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