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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 / June 2026 / P220016

PMA approved

HepQuant SHUNT® Liver Diagnostic Test

Hepquant, LLC · Jun 18, 2026 · P220016 · In the directory

FDA approved the HepQuant SHUNT® Liver Diagnostic Test from Hepquant, LLC on Jun 18, 2026 under P220016, an original premarket approval. The device falls under product code SIO, Test For Esophageal Varices as a Class 3 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 14, 2022. The decision came 1373 days later.

This is the only decision on file for Hepquant, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P220016?

P220016 is the FDA PMA for HepQuant SHUNT® Liver Diagnostic Test, submitted by Hepquant, LLC. FDA's decision date was Jun 18, 2026, under product code SIO (Test For Esophageal Varices).

Who makes the HepQuant SHUNT® Liver Diagnostic Test?

Hepquant, LLC, based in Aurora, CO, is the applicant of record for P220016. The company is listed in the MedDevice Startups directory.

How long did the P220016 review take?

FDA received the submission on Sep 14, 2022 and issued its decision on Jun 18, 2026, 1373 days later.

← All decisions in June 2026