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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 a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-05-30 under approval 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. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K243505.

When was 5008X Hemodialysis System approved by the FDA?

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

What company makes 5008X Hemodialysis System?

5008X Hemodialysis System is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for 5008X Hemodialysis System?

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

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Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, 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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