Thrive 2-in-1 Breast Pump (Model P3)
FDA 510(k) clearance K250350 · decided 2025-07-15
Clearance details
- K-number
- K250350
- Device name
- Thrive 2-in-1 Breast Pump (Model P3)
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-07
- Decision date
- 2025-07-15
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.