510(k) · Cleared
ClearedArgos Infinity (Rev. 1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retia Medical Systems, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Feb 13, 2026 as substantially equivalent to K181372 (Retia Medical, LLC, 2018) after a 143-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Feb 13, 2026
- Review
- 143 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023960 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70 | Lidco, Ltd. | 2003 | — |
| −1 | K181372 | Argos | Retia Medical, LLC | 2018 | — |
| 0 (this device) | K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXG device
- #1 K251275 VitalStream ART Connect; VitalStream-Hemoscore 10.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181372 | ArgosSummary page 5…21 CFR 870.1435 Product Code: DXG 3. Legally Marketed Predicate Device Predicate Name and 510(k) Number: Predicate #: K181372 Predicate Trade Name: Argos Product Code: DXG 4. Device Description Summary The proposed “Argos Infinity,” (AI) is a “Software… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K181372.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Argos Infinity is intended for use in adult patients (18 years and older). It is designed to provide clinicians with continuous hemodynamic monitoring, including cardiac output and derived parameters, for patients who receive radial arterial blood pressure catheters The Argos Infinity software is used for the continuous measurement of cardiac output from an intravascular radial arterial blood pressure signal. This signal is derived from a blood pressure…
Read the full statement (110 words)
Argos Infinity is intended for use in adult patients (18 years and older). It is designed to provide clinicians with continuous hemodynamic monitoring, including cardiac output and derived parameters, for patients who receive radial arterial blood pressure catheters
The Argos Infinity software is used for the continuous measurement of cardiac output from an intravascular radial arterial blood pressure signal. This signal is derived from a blood pressure signal transmitted over a computer network from a vital signs monitor. The device is intended to be used by clinicians at the bedside or in remote settings to assess advanced hemodynamics of patients in an operating room or in an intensive care unit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253092: Argos Infinity (Rev. 1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253092
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026