Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
FDA 510(k) clearance K260538 · decided 2026-06-17
Clearance details
- K-number
- K260538
- Device name
- Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
- Applicant
- Shenzhen Root Innovation Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-17
- Decision date
- 2026-06-17
- Days to decision
- 120 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.