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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 / December 2025 / K251091

510(k) cleared

Lipids

Truvian Health · Dec 30, 2025 · K251091

FDA cleared the Lipids from Truvian Health on Dec 30, 2025 under K251091, a traditional 510(k). The device falls under product code CHH, Enzymatic Esterase--Oxidase, Cholesterol, regulated at 21 CFR 862.1175 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 10, 2025. The decision came 264 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), K251074 (Tru Liver Health Test Panel), K251058 (Tru Kidney Health Test Panel; Tru Analyzer).

Questions & Answers

What did FDA clear under K251091?

K251091 is the FDA 510(k) for Lipids, submitted by Truvian Health. FDA's decision date was Dec 30, 2025, under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol).

Who makes the Lipids?

Truvian Health, based in San Diego, CA, is the applicant of record for K251091.

How long did the K251091 review take?

FDA received the submission on Apr 10, 2025 and issued its decision on Dec 30, 2025, 264 days later.

← All decisions in December 2025

Sources