AquaA
K-Number: K252181 · 2025-09-09
ApplicantFresenius Medical Care North America
Decision Date2025-09-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AquaA is a medical device manufactured by Fresenius Medical Care North America. It received FDA 510(k) clearance on 2025-09-09 under approval number K252181. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AquaA?
AquaA is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Fresenius Medical Care North America. The 510(k) number is K252181.
When was AquaA approved by the FDA?
AquaA received FDA 510(k) clearance on 2025-09-09, under approval number K252181.
What company makes AquaA?
AquaA is manufactured by Fresenius Medical Care North America.
What is the FDA product code for AquaA?
The FDA product code for AquaA is FIP.
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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.