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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2025-09-09 under 510(k) 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. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K252181.

When did AquaA receive FDA 510(k) clearance?

AquaA received FDA 510(k) clearance on 2025-09-09, under 510(k) number K252181.

Who is the listed applicant for AquaA?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaA?

The FDA product code for AquaA is FIP.

Other records listing Fresenius Medical Care North America as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.K231410RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC

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.

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