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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 / K251401

510(k) cleared

PennPET Explorer Positron Emission Tomograph

Trustees of the University of Pennsylvania · Nov 25, 2025 · K251401

FDA cleared the PennPET Explorer Positron Emission Tomograph from Trustees of the University of Pennsylvania on Nov 25, 2025 under K251401, a traditional 510(k). The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 6, 2025. The decision came 203 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 Trustees of the University of Pennsylvania in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251401?

K251401 is the FDA 510(k) for PennPET Explorer Positron Emission Tomograph, submitted by Trustees of the University of Pennsylvania. FDA's decision date was Nov 25, 2025, under product code KPS (System, Tomography, Computed, Emission).

Who makes the PennPET Explorer Positron Emission Tomograph?

Trustees of the University of Pennsylvania, based in Philadelphia, PA, is the applicant of record for K251401.

How long did the K251401 review take?

FDA received the submission on May 6, 2025 and issued its decision on Nov 25, 2025, 203 days later.

← All decisions in November 2025