Wearable Breast Pump (Model W12)— 510(k) K252420

Substantially Equivalent

Shenzhen TPH Technology Co., Ltd.

FDA 510(k) clearance K252420 for Wearable Breast Pump (Model W12), Substantially Equivalent on 2026-02-13. Applicant: Shenzhen TPH Technology Co., Ltd..

Clearance details

Applicant: Shenzhen TPH Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-08-01
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.