eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)— 510(k) K250207

Substantially Equivalent

Anker Innovations Limited

FDA 510(k) clearance K250207 for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03), Substantially Equivalent on 2025-08-11. Applicant: Anker Innovations Limited.

Clearance details

Applicant: Anker Innovations Limited
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-01-24
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.