HGX · Pump, Breast, Powered
Obstetrics/Gynecology · 21 CFR 884.5160 · Class 2
Overview
| Product Code | HGX |
|---|---|
| Device Name | Pump, Breast, Powered |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 234)
Showing 20 most recent of 234 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260239 | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | Apr 22, 2026 | SESE |
| K253510 | Freestyle Mini Hands-free | Medela, LLC | Apr 10, 2026 | SESE |
| K260033 | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | Apr 8, 2026 | SESE |
| 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. | Apr 8, 2026 | SESE |
| 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. | Apr 7, 2026 | SESE |
| K250208 | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | Apr 6, 2026 | SESE |
| K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | Apr 3, 2026 | SESE |
| K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | Mar 12, 2026 | SESE |
| 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. | Mar 9, 2026 | SESE |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | Feb 13, 2026 | SESE |
| K252422 | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | Feb 13, 2026 | SESE |
| K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | Feb 13, 2026 | SESE |
| K251423 | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | Feb 6, 2026 | SESE |
| K253498 | Pump In Style® Pro+ | Medela, LLC | Jan 22, 2026 | SESE |
| 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. | Dec 23, 2025 | SESE |
| K252754 | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | Dec 19, 2025 | SESE |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | Dec 19, 2025 | SESE |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | Nov 25, 2025 | SESE |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | Oct 29, 2025 | SESE |
| K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | Oct 27, 2025 | SESE |
Top Applicants
- Shenzhen TPH Technology Co., Ltd. — 19 clearances
- Medela, Inc. — 7 clearances
- Medela, LLC — 7 clearances
- Shenzhen Root Innovation Technology Co., Ltd. — 7 clearances
- Evenflo Company, Inc. — 6 clearances
