FDA 510(k)

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

N.º K: K252459 · 2026-02-10

SolicitanteFresenius Medical Care Renal Therapies Group, LLC

Fecha de decisión2026-02-10

Código de productoKDI

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Fresenius Medical Care Renal Therapies Group, LLC como solicitante

K261267Careflux H60;Careflux H70;Careflux V500 K252377NxStage System One with NxView K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)K253518FX CorAL 40; FX CorAL 50 K250634BCM2-Body Composition Monitor K250471AquaC UNO H

Ver todos los 48 dispositivos →

Dispositivos relacionados (Código: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC K243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.