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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K252459

510(k) cleared

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

Fresenius Medical Care Renal Therapies Group, LLC · Feb 10, 2026 · K252459

FDA cleared the multiFlux 130 (F00013123); multiFlux 160 (F00013124) from Fresenius Medical Care Renal Therapies Group, LLC on Feb 10, 2026 under K252459, a traditional 510(k). The device falls under product code KDI, Dialyzer, High Permeability With Or Without Sealed Dialysate System, regulated at 21 CFR 876.5860 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 5, 2025. The decision came 189 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fresenius Medical Care Renal Therapies Group, LLC has 8 other decisions in the tracker over the last 12 months: K261267 (Careflux H60;Careflux H70;Careflux V500), K252377 (NxStage System One with NxView), K253462 (NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)), K253518 (FX CorAL 40; FX CorAL 50).

Questions & Answers

What did FDA clear under K252459?

K252459 is the FDA 510(k) for multiFlux 130 (F00013123); multiFlux 160 (F00013124), submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Feb 10, 2026, under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).

Who makes the multiFlux 130 (F00013123); multiFlux 160 (F00013124)?

Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K252459.

How long did the K252459 review take?

FDA received the submission on Aug 5, 2025 and issued its decision on Feb 10, 2026, 189 days later.

← All decisions in February 2026