WHERE ARE YOU?

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 / December 2025 / K251074

510(k) cleared

Tru Liver Health Test Panel

Truvian Health · Dec 19, 2025 · K251074

FDA cleared the Tru Liver Health Test Panel from Truvian Health on Dec 19, 2025 under K251074, a traditional 510(k). The device falls under product code CJE, Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, regulated at 21 CFR 862.1050 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 8, 2025. The decision came 255 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Truvian Health has 3 other decisions in the tracker over the last 12 months: K251157 (Core Metabolic), K251091 (Lipids), K251058 (Tru Kidney Health Test Panel; Tru Analyzer).

Questions & Answers

What did FDA clear under K251074?

K251074 is the FDA 510(k) for Tru Liver Health Test Panel, submitted by Truvian Health. FDA's decision date was Dec 19, 2025, under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes).

Who makes the Tru Liver Health Test Panel?

Truvian Health, based in San Diego, CA, is the applicant of record for K251074.

How long did the K251074 review take?

FDA received the submission on Apr 8, 2025 and issued its decision on Dec 19, 2025, 255 days later.

← All decisions in December 2025

Sources