DIASAFEplusUS (F00013010)
K-Number: K251851 · 2025-10-09
Decision Date2025-10-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DIASAFEplusUS (F00013010) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-10-09 under approval 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. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K251851.
When was DIASAFEplusUS (F00013010) approved by the FDA?
DIASAFEplusUS (F00013010) received FDA 510(k) clearance on 2025-10-09, under approval number K251851.
What company makes DIASAFEplusUS (F00013010)?
DIASAFEplusUS (F00013010) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for DIASAFEplusUS (F00013010)?
The FDA product code for DIASAFEplusUS (F00013010) is FIP.
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
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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.