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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 / K250794

510(k) cleared

InVera Infusion Device

Invera Medical · Mar 12, 2026 · K250794

FDA cleared the InVera Infusion Device from Invera Medical on Mar 12, 2026 under K250794, a traditional 510(k). The device falls under product code KRA, Catheter, Continuous Flush, regulated at 21 CFR 870.1210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 14, 2025. The decision came 363 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K250794?

K250794 is the FDA 510(k) for InVera Infusion Device, submitted by Invera Medical. FDA's decision date was Mar 12, 2026, under product code KRA (Catheter, Continuous Flush).

Who makes the InVera Infusion Device?

Invera Medical, based in Galway, is the applicant of record for K250794.

How long did the K250794 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Mar 12, 2026, 363 days later.

← All decisions in March 2026