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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 / April 2026 / K254066

510(k) cleared

Etiometry Platform

Etiometry, Inc. · Apr 3, 2026 · K254066

FDA cleared the Etiometry Platform from Etiometry, Inc. on Apr 3, 2026 under K254066, a special 510(k). The device falls under product code PPW, Adjunctive Cardiovascular Status Indicator, regulated at 21 CFR 870.2200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 18, 2025. The decision came 106 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K254066?

K254066 is the FDA 510(k) for Etiometry Platform, submitted by Etiometry, Inc.. FDA's decision date was Apr 3, 2026, under product code PPW (Adjunctive Cardiovascular Status Indicator).

Who makes the Etiometry Platform?

Etiometry, Inc., based in Dedham, MA, is the applicant of record for K254066.

How long did the K254066 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Apr 3, 2026, 106 days later.

← All decisions in April 2026