Cleared Special

Pump In Style? Pro+

K253498 · Medela, LLC · Obstetrics & Gynecology
Jan 2026
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K253498 is an FDA 510(k) clearance for the Pump In Style? Pro+, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on January 22, 2026, 85 days after receiving the submission on October 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K253498 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2025
Decision Date January 22, 2026
Days to Decision 85 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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