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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 / December 2025 / K253518

510(k) cleared

FX CorAL 40; FX CorAL 50

Fresenius Medical Care Renal Therapies Group, LLC · Dec 18, 2025 · K253518

FDA cleared the FX CorAL 40; FX CorAL 50 from Fresenius Medical Care Renal Therapies Group, LLC on Dec 18, 2025 under K253518, a special 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 Nov 12, 2025. The decision came 36 days later, inside the 90 FDA-day goal for a 510(k).

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), K252459 (multiFlux 130 (F00013123); multiFlux 160 (F00013124)), K253462 (NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)).

Questions & Answers

What did FDA clear under K253518?

K253518 is the FDA 510(k) for FX CorAL 40; FX CorAL 50, submitted by Fresenius Medical Care Renal Therapies Group, LLC. FDA's decision date was Dec 18, 2025, under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).

Who makes the FX CorAL 40; FX CorAL 50?

Fresenius Medical Care Renal Therapies Group, LLC, based in Waltham, MA, is the applicant of record for K253518.

How long did the K253518 review take?

FDA received the submission on Nov 12, 2025 and issued its decision on Dec 18, 2025, 36 days later.

← All decisions in December 2025