eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
FDA 510(k) clearance K250207 · decided 2025-08-11
Clearance details
- K-number
- K250207
- Device name
- eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
- Applicant
- Anker Innovations Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-01-24
- Decision date
- 2025-08-11
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- HGX
- Device class
- 2
- Regulation number
- 884.5160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hong Kong, 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.