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FDA 510(k)

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

K-Number: K252459 · 2026-02-10

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2026-02-10
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

multiFlux 130 (F00013123); multiFlux 160 (F00013124) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-02-10 under approval number K252459. 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 multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

multiFlux 130 (F00013123); multiFlux 160 (F00013124) is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K252459.

When was multiFlux 130 (F00013123); multiFlux 160 (F00013124) approved by the FDA?

multiFlux 130 (F00013123); multiFlux 160 (F00013124) received FDA 510(k) clearance on 2026-02-10, under approval number K252459.

What company makes multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

multiFlux 130 (F00013123); multiFlux 160 (F00013124) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

The FDA product code for multiFlux 130 (F00013123); multiFlux 160 (F00013124) is KDI.

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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.

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