WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K261399

510(k) cleared

ELISIO-HX

Nipro Medical Corporation · Jul 28, 2026 · K261399

FDA cleared the ELISIO-HX from Nipro Medical Corporation on Jul 28, 2026 under K261399, a traditional 510(k). The device falls under product code QAX, Hemodialyzer With Expanded Solute Removal Profile, regulated at 21 CFR 876.5862 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Apr 29, 2026. The decision came 90 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: K253047 (PRESSONE), K260533 (ELISIO-H).

Questions & Answers

What did FDA clear under K261399?

K261399 is the FDA 510(k) for ELISIO-HX, submitted by Nipro Medical Corporation. FDA's decision date was Jul 28, 2026, under product code QAX (Hemodialyzer With Expanded Solute Removal Profile).

Who makes the ELISIO-HX?

Nipro Medical Corporation, based in Miami, FL, is the applicant of record for K261399.

How long did the K261399 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Jul 28, 2026, 90 days later.

← All decisions in July 2026

Sources