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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 / March 2026 / K260533

510(k) cleared

ELISIO-H

Nipro Medical Corporation · Mar 19, 2026 · K260533

FDA cleared the ELISIO-H from Nipro Medical Corporation on Mar 19, 2026 under K260533, 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 Feb 17, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Nipro Medical Corporation has 2 other decisions in the tracker over the last 12 months: K261399 (ELISIO-HX), K253047 (PRESSONE).

Questions & Answers

What did FDA clear under K260533?

K260533 is the FDA 510(k) for ELISIO-H, submitted by Nipro Medical Corporation. FDA's decision date was Mar 19, 2026, under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).

Who makes the ELISIO-H?

Nipro Medical Corporation, based in Miami, FL, is the applicant of record for K260533.

How long did the K260533 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Mar 19, 2026, 30 days later.

← All decisions in March 2026

Sources