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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 / K251058

510(k) cleared

Tru Kidney Health Test Panel; Tru Analyzer

Truvian Health · Nov 26, 2025 · K251058

FDA cleared the Tru Kidney Health Test Panel; Tru Analyzer from Truvian Health on Nov 26, 2025 under K251058, a traditional 510(k). The device falls under product code CGX, Alkaline Picrate, Colorimetry, Creatinine, regulated at 21 CFR 862.1225 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 4, 2025. The decision came 236 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), K251074 (Tru Liver Health Test Panel).

Questions & Answers

What did FDA clear under K251058?

K251058 is the FDA 510(k) for Tru Kidney Health Test Panel; Tru Analyzer, submitted by Truvian Health. FDA's decision date was Nov 26, 2025, under product code CGX (Alkaline Picrate, Colorimetry, Creatinine).

Who makes the Tru Kidney Health Test Panel; Tru Analyzer?

Truvian Health, based in San Diego, CA, is the applicant of record for K251058.

How long did the K251058 review take?

FDA received the submission on Apr 4, 2025 and issued its decision on Nov 26, 2025, 236 days later.

← All decisions in November 2025

Sources