eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)— 510(k) K254300

Substantially Equivalent

Anker Innovations Limited

FDA 510(k) clearance K254300 for eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009), Substantially Equivalent on 2026-05-29. Applicant: Anker Innovations Limited.

Clearance details

Applicant: Anker Innovations Limited
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-12-31
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, HK

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.