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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 / January 2026 / K251157

510(k) cleared

Core Metabolic

Truvian Health · Jan 9, 2026 · K251157

FDA cleared the Core Metabolic from Truvian Health on Jan 9, 2026 under K251157, a traditional 510(k). The device falls under product code CIX, Bromcresol Green Dye-Binding, Albumin, regulated at 21 CFR 862.1035 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 15, 2025. The decision came 269 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: K251091 (Lipids), K251074 (Tru Liver Health Test Panel), K251058 (Tru Kidney Health Test Panel; Tru Analyzer).

Questions & Answers

What did FDA clear under K251157?

K251157 is the FDA 510(k) for Core Metabolic, submitted by Truvian Health. FDA's decision date was Jan 9, 2026, under product code CIX (Bromcresol Green Dye-Binding, Albumin).

Who makes the Core Metabolic?

Truvian Health, based in San Diego, CA, is the applicant of record for K251157.

How long did the K251157 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Jan 9, 2026, 269 days later.

← All decisions in January 2026

Sources