FDA Product Code
FDA Product Code HGX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5160
510(k) Clearances — 253 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254203 | Wearable Breast Pump (Model S36) | Shenzhen TPH Technology Co., Ltd. | 2026-09-17 | Traditional | PDF ↗ |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | 2026-09-03 | Traditional | PDF ↗ |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2026-09-01 | Traditional | PDF ↗ |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | 2026-08-21 | Traditional | PDF ↗ |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2026-08-20 | Traditional | PDF ↗ |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | 2026-07-24 | Traditional | PDF ↗ |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | 2026-07-13 | Traditional | PDF ↗ |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | 2026-06-26 | Traditional | PDF ↗ |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 | Traditional | PDF ↗ |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 | Traditional | PDF ↗ |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | 2026-06-12 | Traditional | PDF ↗ |
| K250129 | AViTA Breast Pump | Avita Corporation | 2026-06-11 | Traditional | PDF ↗ |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 | Traditional | PDF ↗ |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | 2026-06-04 | Traditional | PDF ↗ |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | 2026-05-29 | Traditional | PDF ↗ |
| K254244 | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | 2026-05-21 | Traditional | PDF ↗ |
| K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026-05-13 | Traditional | PDF ↗ |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 | Traditional | PDF ↗ |
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2026-04-22 | Traditional | PDF ↗ |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | 2026-04-10 | Traditional | PDF ↗ |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | 2026-04-08 | Traditional | PDF ↗ |
| K254258 | 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. | 2026-04-08 | Traditional | PDF ↗ |
| K253946 | 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. | 2026-04-07 | Traditional | PDF ↗ |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | 2026-04-06 | Traditional | PDF ↗ |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | 2026-04-03 | Traditional | PDF ↗ |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | 2026-03-12 | Abbreviated | PDF ↗ |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 | Traditional | PDF ↗ |
| K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | 2026-02-13 | Traditional | PDF ↗ |
| K252422 | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 | Traditional | PDF ↗ |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | 2026-02-06 | Traditional | PDF ↗ |
| K253498 | Pump In Style® Pro+ | Medela, LLC | 2026-01-22 | Special | PDF ↗ |
| K253072 | 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) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K252754 | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | 2025-11-25 | Traditional | PDF ↗ |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-10-29 | Special | PDF ↗ |
| K252629 | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 | Traditional | PDF ↗ |
| K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025-10-27 | Traditional | PDF ↗ |
| K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-10-22 | Traditional | PDF ↗ |
| K251512 | Hi bebe super (BT-150B) | Bistos Co., Ltd. | 2025-09-25 | Special | PDF ↗ |
| K251377 | Magic InBra | Medela AG | 2025-09-18 | Traditional | PDF ↗ |
| K251754 | Wearable Breast Pump (Model S33) | Shenzhen TPH Technology Co., Ltd. | 2025-09-08 | Traditional | PDF ↗ |
| K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-09-08 | Traditional | PDF ↗ |
| K250383 | Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. | 2025-08-20 | Traditional | PDF ↗ |
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2025-08-13 | Special | PDF ↗ |
| K250207 | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited | 2025-08-11 | Traditional | PDF ↗ |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology Co., Ltd. | 2025-07-31 | Special | PDF ↗ |
| K250350 | Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. | 2025-07-15 | Traditional | PDF ↗ |
| K250368 | Wearable Breast Pump (Model S21) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K242725 | Youha 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. | 2025-05-30 | Traditional | PDF ↗ |
| K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | Shenzhen TPH Technology Co., Ltd. | 2025-05-30 | Traditional | PDF ↗ |
| K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | 2025-04-21 | Abbreviated | PDF ↗ |
| K250829 | Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. | 2025-04-17 | Traditional | PDF ↗ |
| K250152 | 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; | Shenzhen TPH Technology Co., Ltd. | 2025-04-02 | Special | PDF ↗ |
| K250463 | Ameda GLO Wearable Breast Pump (Model W8S) | Shenzhen TPH Technology Co., Ltd. | 2025-03-20 | Special | PDF ↗ |
| K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | 2025-02-21 | Abbreviated | PDF ↗ |
| K242111 | VIVACE | Unimom.Co | 2025-02-06 | Traditional | PDF ↗ |
| K243629 | 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) | Shenzhen Root Innovation Technology Co., , Ltd. | 2024-12-20 | Special | PDF ↗ |
| K241680 | Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co. , Ltd. | 2024-12-19 | Traditional | PDF ↗ |
| K240218 | Electric Breast Pump (F5055) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2024-10-17 | Traditional | PDF ↗ |
| K242125 | Elvie Stride 2 | Chiaro Technology, Ltd. | 2024-09-27 | Special | PDF ↗ |
| K241004 | 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) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2024-09-11 | Traditional | PDF ↗ |
| K231969 | BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | Dongguanshi Yiyingmei Technology Co., Ltd. | 2024-08-30 | Traditional | PDF ↗ |
| K241705 | 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) | Milkmate Products, Inc. | 2024-07-12 | Special | PDF ↗ |
| K240536 | Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. | 2024-07-01 | Traditional | PDF ↗ |
| K241506 | Annabella Double Breast Pump (ADO-US23-1000) | Annabella Tech | 2024-06-27 | Special | PDF ↗ |
| K232774 | Wearable Breast Pump,Model S18 | Ningbo Dearevery Electronic Technology Co., Ltd. | 2024-06-06 | Traditional | PDF ↗ |
| K233913 | 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) | Aoj Health Technology Co., Ltd. | 2024-05-14 | Traditional | PDF ↗ |
| K232477 | Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | 2024-05-09 | Traditional | PDF ↗ |
| K232608 | Duo Hands-free Breast Pump | Medela, LLC | 2024-04-12 | Special | PDF ↗ |
| K232047 | VIVACE | Unimom.Co | 2024-03-28 | Traditional | PDF ↗ |
| K233136 | Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. | 2024-03-13 | Traditional | PDF ↗ |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | Shenzhen Root Innovation Technology Co., Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K231785 | Perifit Pump | X6 Innovations | 2024-01-26 | Traditional | PDF ↗ |
| K232466 | Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. | 2024-01-19 | Traditional | PDF ↗ |
| K230481 | Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K231595 | Electric Breast Pump | Shenzhen Changkun Technology Co., Ltd. | 2023-10-26 | Traditional | PDF ↗ |
| K230570 | Willow Generation 3 Breast Pump | Willow Innovations, Inc. | 2023-10-16 | Traditional | PDF ↗ |
| K230102 | Smart double sides wearable breast pump, Electric bilateral breast pump | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2023-09-21 | Traditional | PDF ↗ |
| K230672 | Annabella Breast Pump | Annabella , Ltd. | 2023-08-04 | Traditional | PDF ↗ |
| K223886 | Wearable Breast Pump (Model S18) | Shenzhen TPH Technology Co., Ltd. | 2023-07-14 | Traditional | PDF ↗ |
| K230469 | Compact Wearable Pump | Lansinoh Laboratories | 2023-06-30 | Traditional | PDF ↗ |
| K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-06-09 | Traditional | PDF ↗ |
| K223329 | Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) | Guangzhou Yongyi Industrial Co., Ltd. | 2023-05-26 | Traditional | PDF ↗ |
| K230590 | ARDO Bellis | Ardo Medical AG | 2023-03-30 | Special | PDF ↗ |
| K223084 | MilkMate Breast Pump | Milkmate Products, Inc. | 2023-03-16 | Traditional | PDF ↗ |
| K223693 | Electric breast pump (model: M5) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-03-09 | Traditional | PDF ↗ |
| K222573 | imani i2Plus Breast Pump | Imani Co. | 2023-03-03 | Traditional | PDF ↗ |
| K222782 | Wearable 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. | 2023-01-13 | Traditional | PDF ↗ |
| K222045 | Wearable Breast Pump (Model S1DW) | Shenzhen TPH Technology Co., Ltd. | 2023-01-04 | Traditional | PDF ↗ |
| K222726 | Smartpump 3.0 Double Electric Breast Pump | Lansinoh Laboratories | 2022-12-23 | Traditional | PDF ↗ |
| K221708 | CIMILRE Free-T2 Plus | Cimilre Co., Ltd. | 2022-12-23 | Traditional | PDF ↗ |
| K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | 2022-12-12 | Traditional | PDF ↗ |
| K221598 | Wearable breast pump | Mayborn (Uk) Limited | 2022-12-09 | Traditional | PDF ↗ |
| K221576 | Ameda Pearl Electric Breast Pump | Ameda, Inc. | 2022-10-12 | Traditional | PDF ↗ |
| K211016 | Powered Breast Pump (Models 7V and 7X) | Haenim Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K220309 | Wearable Breast Pump (Model S10) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2022-06-27 | Traditional | PDF ↗ |
Product code HGX · Class II · Obstetrics/Gynecology. Data: openFDA.