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FDA 510(k)

NxStage System One with NxView

K-Number: K252377 · 2026-05-15

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2026-05-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NxStage System One with NxView 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 2026-05-15 under 510(k) 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. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K252377.

When did NxStage System One with NxView receive FDA 510(k) clearance?

NxStage System One with NxView received FDA 510(k) clearance on 2026-05-15, under 510(k) number K252377.

Who is the listed applicant for NxStage System One with NxView?

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 NxStage System One with NxView?

The FDA product code for NxStage System One with NxView is KDI.

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

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLCK243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.

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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