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FDA 510(k)

AquaC UNO H

K-Number: K250471 · 2025-11-14

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-11-14
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaC UNO H is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-14 under 510(k) number K250471. 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 AquaC UNO H?

AquaC UNO H is a medical device that received FDA 510(k) clearance on 2025-11-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250471.

When did AquaC UNO H receive FDA 510(k) clearance?

AquaC UNO H received FDA 510(k) clearance on 2025-11-14, under 510(k) number K250471.

Who is the listed applicant for AquaC UNO H?

The FDA 510(k) record lists Fresenius Medical Care Renal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaC UNO H?

The FDA product code for AquaC UNO H 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.

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