HGX
- 产品代码
- HGX
- 器械名称
- Pump, Breast, Powered
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 884.5160
- FDA 专业组
- Obstetrics/Gynecology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 250 件
该代码近三年的 510(k)（79 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260643 | 2026-08-21 | Cimilre Co., Ltd. | Cimilre Dual Max | |
| K261298 | 2026-08-20 | Guangdong Youmeng Electrical Technolog | Wearable Electric Breast Pump (YM-8837, YM-8838, YM- | — |
| K260259 | 2026-07-24 | Shenzhen TPH Technology Co., Ltd. | DiscreetDuo Flow Wearable Breast Pump (Model S3) | |
| K261199 | 2026-07-13 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S32A) | |
| K250070 | 2026-06-26 | Shenzhen Changkun Technology Co., Ltd. | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY | |
| K261025 | 2026-06-25 | Shenzhen Qinyi Electronic Technology C | Wearable breast pump (QY-101, QY-102, QY-108) | |
| K254254 | 2026-06-18 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311- | |
| K260538 | 2026-06-17 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420- | |
| K260346 | 2026-06-12 | Polybell (Guangzhou) Limited | Electric Breast Pump (BH627, BH628, BH707, BH709, BH | FDA |
| K250129 | 2026-06-11 | Avita Corporation | AViTA Breast Pump | |
| K260864 | 2026-06-09 | Shenzhen TPH Technology Co., Ltd. | Mother's Nature W1 Warming Wearable Breast Pump | |
| K260956 | 2026-06-04 | Uzinmedicare Co., Ltd. | Spectra Platinum Mini | |
| K254300 | 2026-05-29 | Anker Innovations Limited | eufy Wearable Breast Pump (T600P, T6000, T6001, T600 | |
| K254244 | 2026-05-21 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S39) | |
| K254125 | 2026-05-13 | Fimilla (Shanghai) Maternity & Baby Ar | Electric Breast Pump (HL-3058 II Pro) | |
| K253914 | 2026-04-29 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, | |
| K260239 | 2026-04-22 | Jiangxi AOV Maternity & Baby Products | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV | |
| K253510 | 2026-04-10 | Medela, LLC | Freestyle Mini Hands-free | |
| K260033 | 2026-04-08 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S21A) | |
| K254258 | 2026-04-08 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137- | FDA |
| K253946 | 2026-04-07 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 P | |
| K250208 | 2026-04-06 | Uzinmedicare Co., Ltd. | SPECTRA Wearable 2 | |
| K252744 | 2026-04-03 | Cixi Ruihong Electric Appliance Co., L | Wearable Electric Breast Pump (RH 668, RH 708, RH 71 | |
| K252583 | 2026-03-12 | A Cute Baby, Inc. | Mini Moon electric breast pump (PA221); Moon Wave el | |
| K253934 | 2026-03-09 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380- | |
| K252422 | 2026-02-13 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model W2) | |
| K252420 | 2026-02-13 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model W12) | |
| K253149 | 2026-02-13 | Medela, LLC | Motion InBra (YM-8801) wearable breast pump | |
| K251423 | 2026-02-06 | Uzinmedicare Co., Ltd. | Spectra S1 Pro; Spectra S2 Pro | FDA |
| K253498 | 2026-01-22 | Medela, LLC | Pump In Style® Pro+ | FDA |
| K253072 | 2025-12-23 | Linhejiacheng (Shenzhen) E-Commerce Co | Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C | |
| K252342 | 2025-12-19 | Guangdong Youmeng Electrical Technolog | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM- | |
| K252754 | 2025-12-19 | Guangdong Youmeng Electrical Technolog | Wearable Electric Breast Pump (YM-8803) | |
| K251932 | 2025-11-25 | Uzinmedicare Co., Ltd. | Spectra Platinum | FDA |
| K253283 | 2025-10-29 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, | |
| K252630 | 2025-10-27 | Fimilla (Shanghai) Maternity & Baby Ar | Electric Breast Pump (HL-3060, F5113) | |
| K252629 | 2025-10-27 | Fimilla (Shanghai) Maternity & Baby Ar | Electric Breast Pump (HL-3058, F5112) | |
| K251977 | 2025-10-22 | Ningbo Youhe Electrical Appliance Tech | electric breast pump (FZ-P8); electric breast pump ( | |
| K251512 | 2025-09-25 | Bistos Co., Ltd. | Hi bebe super (BT-150B) | |
| K251377 | 2025-09-18 | Medela AG | Magic InBra | |
| K251394 | 2025-09-08 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP223) | |
| K251754 | 2025-09-08 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S33) | |
| K250383 | 2025-08-20 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model W6) | |
| K252192 | 2025-08-13 | Huizhou Lvb Maternal and Infant Suppli | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P | — |
| K250207 | 2025-08-11 | Anker Innovations Limited | eufy Wearable Breast Pump S1 (T8D02); eufy Wearable | |
| K250843 | 2025-07-31 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model FS12A); Wearable Breast | |
| K250350 | 2025-07-15 | Shenzhen TPH Technology Co., Ltd. | Thrive 2-in-1 Breast Pump (Model P3) | |
| K250365 | 2025-05-30 | Shenzhen TPH Technology Co., Ltd. | Motif Aura Glow breast pump (Model Motif Aura Glow) | |
| K242725 | 2025-05-30 | Ningbo Youhe Electrical Appliance Tech | Youha electric breast pumps (The INs, The INs Gen2, | |
| K250368 | 2025-05-30 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S21) | |
| K243508 | 2025-04-21 | Shenzhen TPH Technology Co., Ltd. | Wearable breast pump (model S12A) | |
| K250829 | 2025-04-17 | Shenzhen TPH Technology Co., Ltd. | Lacevo Wearable Breast Pump (Model S70) | |
| K250152 | 2025-04-02 | Shenzhen TPH Technology Co., Ltd. | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eu | |
| K250463 | 2025-03-20 | Shenzhen TPH Technology Co., Ltd. | Ameda GLO Wearable Breast Pump (Model W8S) | |
| K242850 | 2025-02-21 | Shenzhen TPH Technology Co., Ltd. | Wearable breast pump (model W8) | |
| K242111 | 2025-02-06 | Unimom.Co | VIVACE | |
| K241680 | 2024-12-20 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP311) | — |
| K243629 | 2024-12-20 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP311); Momcozy Wearab | — |
| K241322 | 2024-12-19 | Joytech Healthcare Co. , Ltd. | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, L | |
| K240218 | 2024-10-17 | Fimilla (Shanghai) Maternity & Baby Ar | Electric Breast Pump (F5055) | |
| K242125 | 2024-09-27 | Chiaro Technology, Ltd. | Elvie Stride 2 | |
| K241004 | 2024-09-11 | Huizhou Lvb Maternal and Infant Suppli | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-130 | FDA |
| K231969 | 2024-08-30 | Dongguanshi Yiyingmei Technology Co., | BASEN Wearable Breast Pump (Model: YM-801, YM-803, Y | |
| K241705 | 2024-07-12 | Milkmate Products, Inc. | MilkMate Breast Pump (A0006); MilkMate Kit (sterile, | |
| K240536 | 2024-07-01 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S32) | |
| K241506 | 2024-06-27 | Annabella Tech | Annabella Double Breast Pump (ADO-US23-1000) | FDA |
| K232774 | 2024-06-06 | Ningbo Dearevery Electronic Technology | Wearable Breast Pump,Model S18 | |
| K233913 | 2024-05-14 | Aoj Health Technology Co., Ltd. | Electric Breast Pump (BRP-301); Electric Breast Pump | — |
| K232477 | 2024-05-09 | Jiangxi AOV Maternity & Baby Products | Electric Breast Pump (Models AOV6818, AOV6821, AOV68 | |
| K232608 | 2024-04-12 | Medela, LLC | Duo Hands-free Breast Pump | |
| K232047 | 2024-03-28 | Unimom.Co | VIVACE | |
| K233136 | 2024-03-13 | Hygeia II Medical Group, Inc. | Hygeia Express Powered Breast Pump | FDA |
| K233880 | 2024-03-06 | Shenzhen Root Innovation Technology Co | Momcozy Wearable Breast Pump (BP137); Momcozy Wearab | — |
| K231785 | 2024-01-26 | X6 Innovations | Perifit Pump | |
| K232466 | 2024-01-19 | Guangdong Youmeng Electrical Technolog | Electric Breast Pump, model: YM-8166 | |
| K230481 | 2023-11-03 | Evenflo Feeding, Inc. | Evenflo Premium Double Electric Breast Pump (Model 4 | |
| K231595 | 2023-10-26 | Shenzhen Changkun Technology Co., Ltd. | Electric Breast Pump | — |
| K230570 | 2023-10-16 | Willow Innovations, Inc. | Willow Generation 3 Breast Pump | |
| K230102 | 2023-09-21 | Huizhou Lvb Maternal and Infant Suppli | Smart double sides wearable breast pump, Electric bi |
FDA 官方分类页： HGX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。