Pump In Style® Pro+— 510(k) K253498

Substantially Equivalent

Medela, LLC

FDA 510(k) clearance K253498 for Pump In Style® Pro+, Substantially Equivalent on 2026-01-22. Applicant: Medela, LLC.

Clearance details

Applicant: Medela, LLC
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-10-29
Decision date: 2026-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Mchenry, IL, US

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.