Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)— 510(k) K252192
Substantially EquivalentHuizhou Lvb Maternal and Infant Supplies Co., Ltd.
FDA 510(k) clearance K252192 for Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25), Substantially Equivalent on 2025-08-13. Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Huizhou, CN
Recent devices under product code HGX
view all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K260643 — Cimilre Dual Max
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.