HGX — Pump, Breast, Powered Class II
FDA product code HGX covers "Pump, Breast, Powered", a Class II medical device regulated under 21 CFR 884.5160. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HGX
- Device Class
- Class II
- Regulation Number
- 884.5160
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254203 | shenzhen tph technology co | Wearable Breast Pump (Model S36) | September 17, 2026 |
| K261622 | philips consumer lifestyle | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 | September 3, 2026 |
| K262774 | guangdong horigen mother and baby products co | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | September 1, 2026 |
| K260643 | cimilre co | Cimilre Dual Max | August 21, 2026 |
| K261298 | guangdong youmeng electrical technology co | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | August 20, 2026 |
| K260259 | shenzhen tph technology co | DiscreetDuo Flow Wearable Breast Pump (Model S3) | July 24, 2026 |
| K261199 | shenzhen tph technology co | Wearable Breast Pump (Model S32A) | July 13, 2026 |
| K250070 | shenzhen changkun technology co | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | June 26, 2026 |
| K261025 | shenzhen qinyi electronic technology co | Wearable breast pump (QY-101, QY-102, QY-108) | June 25, 2026 |
| K254254 | shenzhen root innovation technology co | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | June 18, 2026 |
| K260538 | shenzhen root innovation technology co | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | June 17, 2026 |
| K260346 | polybell (guangzhou) limited | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 | June 12, 2026 |
| K250129 | avita corporation | AViTA Breast Pump | June 11, 2026 |
| K260864 | shenzhen tph technology co | Mother's Nature W1 Warming Wearable Breast Pump | June 9, 2026 |
| K260956 | uzinmedicare co | Spectra Platinum Mini | June 4, 2026 |
| K254300 | anker innovations limited | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 | May 29, 2026 |
| K254244 | shenzhen tph technology co | Wearable Breast Pump (Model S39) | May 21, 2026 |
| K254125 | fimilla (shanghai) maternity and baby articles co | Electric Breast Pump (HL-3058 II Pro) | May 13, 2026 |
| K253914 | shenzhen root innovation technology co | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, | April 29, 2026 |
| K260239 | jiangxi aov maternity and baby products co | Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) | April 22, 2026 |