Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
FDA 510(k) clearance K252192 · decided 2025-08-13
Clearance details
- K-number
- K252192
- Device name
- Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
- Applicant
- Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-14
- Decision date
- 2025-08-13
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.