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FDA 510(k)

5008X Hemodialysis System

K-Number: K243505 · 2025-05-30

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-05-30
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

5008X Hemodialysis System 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 2025-05-30 under 510(k) number K243505. 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 5008X Hemodialysis System?

5008X Hemodialysis System is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K243505.

When did 5008X Hemodialysis System receive FDA 510(k) clearance?

5008X Hemodialysis System received FDA 510(k) clearance on 2025-05-30, under 510(k) number K243505.

Who is the listed applicant for 5008X Hemodialysis System?

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 5008X Hemodialysis System?

The FDA product code for 5008X Hemodialysis System is KDI.

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

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 V500K252377NxStage System One with NxViewK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)K253518FX CorAL 40; FX CorAL 50K250634BCM2-Body Composition Monitor

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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, LLCK252377NxStage System One with NxViewFresenius 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, 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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