Electric Breast Pump (HL-3060, F5113)— 510(k) K252630

Substantially Equivalent

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

FDA 510(k) clearance K252630 for Electric Breast Pump (HL-3060, F5113), Substantially Equivalent on 2025-10-27. Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd..

Clearance details

Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-20
Decision date: 2025-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.