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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 / K260255

510(k) cleared

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)

Aventix Medical, Inc. · Mar 27, 2026 · K260255

FDA cleared the AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) from Aventix Medical, Inc. on Mar 27, 2026 under K260255, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 28, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Aventix Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260255?

K260255 is the FDA 510(k) for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001), submitted by Aventix Medical, Inc.. FDA's decision date was Mar 27, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

Aventix Medical, Inc., based in Laguna Hills, CA, is the applicant of record for K260255.

How long did the K260255 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Mar 27, 2026, 58 days later.

← All decisions in March 2026