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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 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 2026-02-10 under 510(k) 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. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K252459.

When did multiFlux 130 (F00013123); multiFlux 160 (F00013124) receive FDA 510(k) clearance?

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

Who is the listed applicant for multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

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 multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

The FDA product code for multiFlux 130 (F00013123); multiFlux 160 (F00013124) 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, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK253412Tablo 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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