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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 / February 2026 / K253092

510(k) cleared

Argos Infinity (Rev. 1.0)

Retia Medical Systems, Inc. · Feb 13, 2026 · K253092

FDA cleared the Argos Infinity (Rev. 1.0) from Retia Medical Systems, Inc. on Feb 13, 2026 under K253092, a traditional 510(k). The device falls under product code DXG, Computer, Diagnostic, Pre-Programmed, Single-Function, regulated at 21 CFR 870.1435 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 23, 2025. The decision came 143 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 Retia Medical Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253092?

K253092 is the FDA 510(k) for Argos Infinity (Rev. 1.0), submitted by Retia Medical Systems, Inc.. FDA's decision date was Feb 13, 2026, under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function).

Who makes the Argos Infinity (Rev. 1.0)?

Retia Medical Systems, Inc., based in White Plains, NY, is the applicant of record for K253092.

How long did the K253092 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Feb 13, 2026, 143 days later.

← All decisions in February 2026