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-staging.innolitics.com/productcode/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 252)

Showing 20 most recent of 252 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261622](/device/K261622.md) | 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. | Sep 3, 2026 | SESE |
| [K262774](/device/K262774.md) | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | Sep 1, 2026 | SESE |
| [K260643](/device/K260643.md) | Cimilre Dual Max | Cimilre Co., Ltd. | Aug 21, 2026 | SESE |
| [K261298](/device/K261298.md) | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | Aug 20, 2026 | SESE |
| [K260259](/device/K260259.md) | DiscreetDuo™ Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | Jul 24, 2026 | SESE |
| [K261199](/device/K261199.md) | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | Jul 13, 2026 | SESE |
| [K250070](/device/K250070.md) | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | Jun 26, 2026 | SESE |
| [K261025](/device/K261025.md) | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | Jun 25, 2026 | SESE |
| [K254254](/device/K254254.md) | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | Jun 18, 2026 | SESE |
| [K260538](/device/K260538.md) | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | Jun 17, 2026 | SESE |
| [K260346](/device/K260346.md) | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | Jun 12, 2026 | SESE |
| [K250129](/device/K250129.md) | AViTA Breast Pump | Avita Corporation | Jun 11, 2026 | SESE |
| [K260864](/device/K260864.md) | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | Jun 9, 2026 | SESE |
| [K260956](/device/K260956.md) | Spectra Platinum Mini | Uzinmedicare Co., Ltd. | Jun 4, 2026 | SESE |
| [K254300](/device/K254300.md) | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | May 29, 2026 | SESE |
| [K254244](/device/K254244.md) | Wearable Breast Pump (Model S39) | Shenzhen TPH Technology Co., Ltd. | May 21, 2026 | SESE |
| [K254125](/device/K254125.md) | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | May 13, 2026 | SESE |
| [K253914](/device/K253914.md) | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. | Apr 29, 2026 | SESE |
| [K260239](/device/K260239.md) | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | Jiangxi AOV Maternity & Baby Products Co., Ltd. | Apr 22, 2026 | SESE |
| [K253510](/device/K253510.md) | Freestyle Mini Hands-free | Medela, LLC | Apr 10, 2026 | SESE |

## Top Applicants

- Shenzhen TPH Technology Co., Ltd. — 23 clearances
- Shenzhen Root Innovation Technology Co., Ltd. — 10 clearances
- Medela, Inc. — 7 clearances
- Medela, LLC — 7 clearances
- Evenflo Company, Inc. — 6 clearances

---

**Source:** [https://fda-staging.innolitics.com/productcode/HGX](https://fda-staging.innolitics.com/productcode/HGX)

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