Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5160](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5160) → HGX — Pump, Breast, Powered # HGX · Pump, Breast, Powered _Obstetrics/Gynecology · 21 CFR 884.5160 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX ## Overview - **Product Code:** HGX - **Device Name:** Pump, Breast, Powered - **Regulation:** [21 CFR 884.5160](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5160) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K260239.md) | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | Apr 22, 2026 | SESE | | [K253510](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253510.md) | Freestyle Mini Hands-free | Medela, LLC | Apr 10, 2026 | SESE | | [K260033](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K260033.md) | Wearable Breast Pump (Model S21A) | Shenzhen TPH Technology Co., Ltd. | Apr 8, 2026 | SESE | | [K254258](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K254258.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253946.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K250208.md) | SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. | Apr 6, 2026 | SESE | | [K252744](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252744.md) | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. | Apr 3, 2026 | SESE | | [K252583](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252583.md) | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | Mar 12, 2026 | SESE | | [K253934](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253934.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253149.md) | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | Feb 13, 2026 | SESE | | [K252422](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252422.md) | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | Feb 13, 2026 | SESE | | [K252420](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252420.md) | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | Feb 13, 2026 | SESE | | [K251423](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K251423.md) | Spectra S1 Pro; Spectra S2 Pro | Uzinmedicare Co., Ltd. | Feb 6, 2026 | SESE | | [K253498](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253498.md) | Pump In Style® Pro+ | Medela, LLC | Jan 22, 2026 | SESE | | [K253072](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253072.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252754.md) | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K252342](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252342.md) | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K251932](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K251932.md) | Spectra Platinum | Uzinmedicare Co., Ltd. | Nov 25, 2025 | SESE | | [K253283](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K253283.md) | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | Shenzhen Root Innovation Technology Co., Ltd. | Oct 29, 2025 | SESE | | [K252630](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX/K252630.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HGX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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