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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 / April 2026 / K253558

510(k) cleared

Luminoah FLOW Enteral Nutrition System

Luminoah · Apr 20, 2026 · K253558

FDA cleared the Luminoah FLOW Enteral Nutrition System from Luminoah on Apr 20, 2026 under K253558, a traditional 510(k). The device falls under product code LZH, Pump, Infusion, Enteral, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 17, 2025. The decision came 154 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 Luminoah in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253558?

K253558 is the FDA 510(k) for Luminoah FLOW Enteral Nutrition System, submitted by Luminoah. FDA's decision date was Apr 20, 2026, under product code LZH (Pump, Infusion, Enteral).

Who makes the Luminoah FLOW Enteral Nutrition System?

Luminoah, based in Charlottesville, VA, is the applicant of record for K253558.

How long did the K253558 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 20, 2026, 154 days later.

← All decisions in April 2026