Pump In Style® Pro+
K-Number: K253498 · 2026-01-22
ApplicantMedela, LLC
Decision Date2026-01-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Pump In Style® Pro+ is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2026-01-22 under approval number K253498. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pump In Style® Pro+?
Pump In Style® Pro+ is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Medela, LLC. The 510(k) number is K253498.
When was Pump In Style® Pro+ approved by the FDA?
Pump In Style® Pro+ received FDA 510(k) clearance on 2026-01-22, under approval number K253498.
What company makes Pump In Style® Pro+?
Pump In Style® Pro+ is manufactured by Medela, LLC.
What is the FDA product code for Pump In Style® Pro+?
The FDA product code for Pump In Style® Pro+ is HGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.