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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 / K252696

510(k) cleared

LEGACY

Phasor Health, LLC · Nov 21, 2025 · K252696

FDA cleared the LEGACY from Phasor Health, LLC on Nov 21, 2025 under K252696, a traditional 510(k). The device falls under product code HBG, Drills, Burrs, Trephines & Accessories (Manual), regulated at 21 CFR 882.4300 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 27, 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: K252514 (EVAC-MRI), K252060 (GREEN).

Questions & Answers

What did FDA clear under K252696?

K252696 is the FDA 510(k) for LEGACY, submitted by Phasor Health, LLC. FDA's decision date was Nov 21, 2025, under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)).

Who makes the LEGACY?

Phasor Health, LLC, based in Houston, TX, is the applicant of record for K252696.

How long did the K252696 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Nov 21, 2025, 86 days later.

← All decisions in November 2025

Sources