Cleared Traditional

K253092 - Argos Infinity (Rev. 1.0)

K253092 is an FDA 510(k) clearance for Argos Infinity (Rev. 1.0), manufactured by Retia Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K253092 · Retia Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
143d
Days
Class 2
Risk

K253092 is an FDA 510(k) clearance for the Argos Infinity (Rev. 1.0). Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Retia Medical Systems, Inc. (White Plains, US). The FDA issued a Cleared decision on February 13, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Retia Medical Systems, Inc. devices

FDA 510(k) Submission Details - K253092

510(k) Number K253092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K253092.
VitalStream ART Connect
K251275 · Caretaker Medical · Sep 2025
Cogent™ Hemodynamic Monitoring System
K232048 · Icu Medical · Dec 2023
Hypotension Decision Assist Model HDA-OR2
K212529 · Directed Systems, Ltd. · Nov 2021
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · Pulsion Medical Systems SE · Apr 2020
EV1000 Clinical Platform
K193179 · Edwards Lifesciences, LLC · Dec 2019
Hypotension Decision Assist
K190955 · Directed Systems, Ltd. · Nov 2019