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FDA 510(k)

DIASAFEplusUS (F00013010)

K-Number: K251851 · 2025-10-09

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-10-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIASAFEplusUS (F00013010) 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 2025-10-09 under 510(k) number K251851. 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 DIASAFEplusUS (F00013010)?

DIASAFEplusUS (F00013010) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K251851.

When did DIASAFEplusUS (F00013010) receive FDA 510(k) clearance?

DIASAFEplusUS (F00013010) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K251851.

Who is the listed applicant for DIASAFEplusUS (F00013010)?

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 DIASAFEplusUS (F00013010)?

The FDA product code for DIASAFEplusUS (F00013010) is FIP.

Other records listing Fresenius Medical Care Renal Therapies Group, LLC as applicant

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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, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT 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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