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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K252060

510(k) cleared

GREEN

Phasor Health, LLC · Oct 31, 2025 · K252060

FDA cleared the GREEN from Phasor Health, LLC on Oct 31, 2025 under K252060, a traditional 510(k). The device falls under product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered), regulated at 21 CFR 882.4310 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 1, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Phasor Health, LLC has 2 other decisions in the tracker over the last 12 months: K252696 (LEGACY), K252514 (EVAC-MRI).

Questions & Answers

What did FDA clear under K252060?

K252060 is the FDA 510(k) for GREEN, submitted by Phasor Health, LLC. FDA's decision date was Oct 31, 2025, under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)).

Who makes the GREEN?

Phasor Health, LLC, based in Houston, TX, is the applicant of record for K252060.

How long did the K252060 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Oct 31, 2025, 122 days later.

← All decisions in October 2025

Sources