510(k) · Cleared
ClearedArgos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retia Medical, LLC · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Dec 13, 2018 as substantially equivalent to K043065 (Edwards Lifesciences, LLC, 2005) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Dec 13, 2018
- Review
- 204 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023960 (2003). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023960 Lidcoplus Hemodynamic Monitor System, Model HM 70Lidco, Ltd. · 2003
- This deviceK181372 ArgosRetia Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK253092 Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251275 VitalStream ART Connect; VitalStream-HemoCaretaker Medical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70 | Lidco, Ltd. | 2003 | — |
| 0 (this device) | K181372 | Argos | Retia Medical, LLC | 2018 | — |
| +1 | K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026 | — |
| +1 | K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 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? (2)
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 |
|---|---|---|---|
| * | K043065 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1PSummary page 4…DXG 5.3. Predicate Device Predicate Name and 510(k) Number: Primary Predicate: Edwards Lifesciences: Flotrac Vigileo Arterial Pressure Cardiac Output (APCO) Monitor (K043065). Secondary Predicate: LiDCOplus monitor (K023960). 5.4. Device Description The Argos Monitor is a portable hemodynamic monitor t… | 2005 |
| * | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70Summary page 4…10(k) Number: Primary Predicate: Edwards Lifesciences: Flotrac Vigileo Arterial Pressure Cardiac Output (APCO) Monitor (K043065). Secondary Predicate: LiDCOplus monitor (K023960). 5.4. Device Description The Argos Monitor is a portable hemodynamic monitor that calculates Cardiac Output and other derived pa… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2018, 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?
The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18. It is intended to be used
as a hemodynamic monitor for monitoring cardiac output and its derived parameters on patients in the intensive care unit
or the operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181372: Argos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181372
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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