Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )— 510(k) K260538

Substantially Equivalent

Shenzhen Root Innovation Technology Co., Ltd.

FDA 510(k) clearance K260538 for Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ), Substantially Equivalent on 2026-06-17. Applicant: Shenzhen Root Innovation Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Root Innovation Technology Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2026-02-17
Decision date: 2026-06-17
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.