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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 / November 2025 / K252514

510(k) cleared

EVAC-MRI

Phasor Health, LLC · Nov 5, 2025 · K252514

FDA cleared the EVAC-MRI from Phasor Health, LLC on Nov 5, 2025 under K252514, a traditional 510(k). The device falls under product code JXG, Shunt, Central Nervous System And Components, regulated at 21 CFR 882.5550 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 11, 2025. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Phasor Health, LLC has 2 other decisions in the tracker over the last 12 months: K252696 (LEGACY), K252060 (GREEN).

Questions & Answers

What did FDA clear under K252514?

K252514 is the FDA 510(k) for EVAC-MRI, submitted by Phasor Health, LLC. FDA's decision date was Nov 5, 2025, under product code JXG (Shunt, Central Nervous System And Components).

Who makes the EVAC-MRI?

Phasor Health, LLC, based in Houston, TX, is the applicant of record for K252514.

How long did the K252514 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Nov 5, 2025, 86 days later.

← All decisions in November 2025

Sources