Atlas FDA

HGX

248 FDA 510(k) clearances · Product code

145 daysmedian time to decision
309 days90th percentile
248clearances measured

FDA profile

Official device name
Pump, Breast, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5160
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 119 · 2022: 154 · 2023: 200 · 2024: 118 · 2025: 70 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (K260259)Shenzhen TPH Technology Co., Ltd.2026-07-24
Wearable Breast Pump (Model S32A) (K261199)Shenzhen TPH Technology Co., Ltd.2026-07-13
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (K250070)Shenzhen Changkun Technology Co., Ltd.2026-06-26
Wearable breast pump (QY-101, QY-102, QY-108) (K261025)Shenzhen Qinyi Electronic Technology Co., Ltd.2026-06-25
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (K254254)Shenzhen Root Innovation Technology Co., Ltd.2026-06-18
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (K260538)Shenzhen Root Innovation Technology Co., Ltd.2026-06-17
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) (K260346)Polybell (Guangzhou) Limited2026-06-12
AViTA Breast Pump (K250129)Avita Corporation2026-06-11
Mother's Nature W1 Warming Wearable Breast Pump (K260864)Shenzhen TPH Technology Co., Ltd.2026-06-09
Spectra Platinum Mini (K260956)Uzinmedicare Co., Ltd.2026-06-04
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) (K254300)Anker Innovations Limited2026-05-29
Wearable Breast Pump (Model S39) (K254244)Shenzhen TPH Technology Co., Ltd.2026-05-21
Electric Breast Pump (HL-3058 II Pro) (K254125)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2026-05-13
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) (K253914)Shenzhen Root Innovation Technology Co., Ltd.2026-04-29
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) (K260239)Jiangxi AOV Maternity & Baby Products Co., Ltd.2026-04-22
Freestyle Mini Hands-free (K253510)Medela, LLC2026-04-10
Wearable Breast Pump (Model S21A) (K260033)Shenzhen TPH Technology Co., Ltd.2026-04-08
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.2026-04-08
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.2026-04-07
SPECTRA Wearable 2 (K250208)Uzinmedicare Co., Ltd.2026-04-06
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (K252744)Cixi Ruihong Electric Appliance Co., Ltd.2026-04-03
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (K252583)A Cute Baby, Inc.2026-03-12
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.2026-03-09
Motion InBra (YM-8801) wearable breast pump (K253149)Medela, LLC2026-02-13
Wearable Breast Pump (Model W2) (K252422)Shenzhen TPH Technology Co., Ltd.2026-02-13
Wearable Breast Pump (Model W12) (K252420)Shenzhen TPH Technology Co., Ltd.2026-02-13
Spectra S1 Pro; Spectra S2 Pro (K251423)Uzinmedicare Co., Ltd.2026-02-06
Pump In Style® Pro+ (K253498)Medela, LLC2026-01-22
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.2025-12-23
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (K252342)Guangdong Youmeng Electrical Technology Co., Ltd.2025-12-19
Wearable Electric Breast Pump (YM-8803) (K252754)Guangdong Youmeng Electrical Technology Co., Ltd.2025-12-19
Spectra Platinum (K251932)Uzinmedicare Co., Ltd.2025-11-25
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (K253283)Shenzhen Root Innovation Technology Co., Ltd.2025-10-29
Electric Breast Pump (HL-3058, F5112) (K252629)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2025-10-27
Electric Breast Pump (HL-3060, F5113) (K252630)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2025-10-27
electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) (K251977)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2025-10-22
Hi bebe super (BT-150B) (K251512)Bistos Co., Ltd.2025-09-25
Magic InBra (K251377)Medela AG2025-09-18
Wearable Breast Pump (Model S33) (K251754)Shenzhen TPH Technology Co., Ltd.2025-09-08
Momcozy Wearable Breast Pump (BP223) (K251394)Shenzhen Root Innovation Technology Co., Ltd.2025-09-08
Wearable Breast Pump (Model W6) (K250383)Shenzhen TPH Technology Co., Ltd.2025-08-20
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) (K252192)Huizhou Lvb Maternal and Infant Supplies Co., Ltd.2025-08-13
eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) (K250207)Anker Innovations Limited2025-08-11
Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) (K250843)Shenzhen TPH Technology Co., Ltd.2025-07-31
Thrive 2-in-1 Breast Pump (Model P3) (K250350)Shenzhen TPH Technology Co., Ltd.2025-07-15
Wearable Breast Pump (Model S21) (K250368)Shenzhen TPH Technology Co., Ltd.2025-05-30
Motif Aura Glow breast pump (Model Motif Aura Glow) (K250365)Shenzhen TPH Technology Co., Ltd.2025-05-30
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) (K242725)Ningbo Youhe Electrical Appliance Technology Co., Ltd.2025-05-30
Wearable breast pump (model S12A) (K243508)Shenzhen TPH Technology Co., Ltd.2025-04-21
Lacevo Wearable Breast Pump (Model S70) (K250829)Shenzhen TPH Technology Co., Ltd.2025-04-17
eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; (K250152)Shenzhen TPH Technology Co., Ltd.2025-04-02
Ameda GLO Wearable Breast Pump (Model W8S) (K250463)Shenzhen TPH Technology Co., Ltd.2025-03-20
Wearable breast pump (model W8) (K242850)Shenzhen TPH Technology Co., Ltd.2025-02-21
VIVACE (K242111)Unimom.Co2025-02-06
Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430) (K243629)Shenzhen Root Innovation Technology Co., , Ltd.2024-12-20
Momcozy Wearable Breast Pump (BP311) (K241680)Shenzhen Root Innovation Technology Co., Ltd.2024-12-20
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (K241322)Joytech Healthcare Co. , Ltd.2024-12-19
Electric Breast Pump (F5055) (K240218)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2024-10-17
Elvie Stride 2 (K242125)Chiaro Technology, Ltd.2024-09-27
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) (K241004)Huizhou Lvb Maternal and Infant Supplies Co., Ltd.2024-09-11
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) (K231969)Dongguanshi Yiyingmei Technology Co., Ltd.2024-08-30
MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) (K241705)Milkmate Products, Inc.2024-07-12
Wearable Breast Pump (Model S32) (K240536)Shenzhen TPH Technology Co., Ltd.2024-07-01
Annabella Double Breast Pump (ADO-US23-1000) (K241506)Annabella Tech2024-06-27
Wearable Breast Pump,Model S18 (K232774)Ningbo Dearevery Electronic Technology Co., Ltd.2024-06-06
Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) (K233913)Aoj Health Technology Co., Ltd.2024-05-14
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) (K232477)Jiangxi AOV Maternity & Baby Products Co., Ltd.2024-05-09
Duo Hands-free Breast Pump (K232608)Medela, LLC2024-04-12
VIVACE (K232047)Unimom.Co2024-03-28
Hygeia Express Powered Breast Pump (K233136)Hygeia II Medical Group, Inc.2024-03-13
Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) (K233880)Shenzhen Root Innovation Technology Co., Ltd.2024-03-06
Perifit Pump (K231785)X6 Innovations2024-01-26
Electric Breast Pump, model: YM-8166 (K232466)Guangdong Youmeng Electrical Technology Co., Ltd.2024-01-19
Evenflo Premium Double Electric Breast Pump (Model 4018) (K230481)Evenflo Feeding, Inc.2023-11-03
Electric Breast Pump (K231595)Shenzhen Changkun Technology Co., Ltd.2023-10-26
Willow Generation 3 Breast Pump (K230570)Willow Innovations, Inc.2023-10-16
Smart double sides wearable breast pump, Electric bilateral breast pump (K230102)Huizhou Lvb Maternal and Infant Supplies Co., Ltd.2023-09-21
Annabella Breast Pump (K230672)Annabella , Ltd.2023-08-04
Wearable Breast Pump (Model S18) (K223886)Shenzhen TPH Technology Co., Ltd.2023-07-14
Compact Wearable Pump (K230469)Lansinoh Laboratories2023-06-30
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) (K230776)Shenzhen Lutejiacheng Technology Co., Ltd.2023-06-09
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) (K223329)Guangzhou Yongyi Industrial Co., Ltd.2023-05-26
ARDO Bellis (K230590)Ardo Medical AG2023-03-30
MilkMate Breast Pump (K223084)Milkmate Products, Inc.2023-03-16
Electric breast pump (model: M5) (K223693)Shenzhen Lutejiacheng Technology Co., Ltd.2023-03-09
imani i2Plus Breast Pump (K222573)Imani Co.2023-03-03
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) (K222782)Zhejiang Carebao Co., Ltd.2023-01-13
Wearable Breast Pump (Model S1DW) (K222045)Shenzhen TPH Technology Co., Ltd.2023-01-04
Smartpump 3.0 Double Electric Breast Pump (K222726)Lansinoh Laboratories2022-12-23
CIMILRE Free-T2 Plus (K221708)Cimilre Co., Ltd.2022-12-23
Spectra Wearable (K220926)Uzinmedicare Co., Ltd.2022-12-12
Wearable breast pump (K221598)Mayborn (Uk) Limited2022-12-09
Ameda Pearl Electric Breast Pump (K221576)Ameda, Inc.2022-10-12
Powered Breast Pump (Models 7V and 7X) (K211016)Haenim Co., Ltd.2022-06-29
Wearable Breast Pump (Model S10) (K220309)Shenzhen Lutejiacheng Technology Co., Ltd.2022-06-27
Wearable Breast Pump (Model S9) (K220596)Shenzhen TPH Technology Co., Ltd.2022-05-26
Electric Breast Pump (K212564)Guangdong Horigen Mother & Baby Products Co., Ltd.2022-05-06
ARDO Alyssa (K212773)Ardo Medical AG2022-04-15
Fit Pro Breast Pump (K212955)Hygeia II Medical Group, Inc.2022-03-15
Electric Breast Pump (K211024)Shantou Huihengqi Electronic Technology Co., Ltd.2022-02-11
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