NxStage System One with NxView
K-Number: K252377 · 2026-05-15
Decision Date2026-05-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NxStage System One with NxView is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-05-15 under approval number K252377. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NxStage System One with NxView?
NxStage System One with NxView is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K252377.
When was NxStage System One with NxView approved by the FDA?
NxStage System One with NxView received FDA 510(k) clearance on 2026-05-15, under approval number K252377.
What company makes NxStage System One with NxView?
NxStage System One with NxView is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for NxStage System One with NxView?
The FDA product code for NxStage System One with NxView is KDI.
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.