Cleared Traditional

Argos Infinity (Rev. 1.0)

K253092 · Retia Medical Systems, Inc. · Cardiovascular

Feb 2026

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K253092 is an FDA 510(k) clearance for the Argos Infinity (Rev. 1.0), a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Retia Medical Systems, Inc. (White Plains, US). The FDA issued a Cleared decision on February 13, 2026, 143 days after receiving the submission on September 23, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K253092 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2025
Decision Date	February 13, 2026
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF