510(k) · Cleared
ClearedLidcoplus Hemodynamic Monitor System, Model HM 70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lidco, Ltd. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jan 9, 2003 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jan 9, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK023960 Lidcoplus Hemodynamic Monitor System, Model HM 70Lidco, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK181372 ArgosRetia Medical, LLC · 2018
- Descendant · cites it directly · 2 of its ownK080116 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK113821 Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK253092 Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251275 VitalStream ART Connect; VitalStream-HemoCaretaker Medical · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181372ArgosRetia Medical, LLC · 2018 · cites it directly2descendants
- K080116Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2008 · cites it directly2descendants
- K113821Transonic Costatus Cardiac Output SystemTransonic Systems, Inc. · 2012 · cites it directly1descendant
- K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc. · 2026 · 2 generations on0descendants
- K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023960 | Lidcoplus Hemodynamic Monitor System, Model HM 70 | Lidco, Ltd. | 2003 | — |
| +1 | K181372 | Argos | Retia Medical, LLC | 2018 | — |
| +1 | K080116 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2008 | 1 |
| +1 | K113821 | Transonic Costatus Cardiac Output System | Transonic Systems, Inc. | 2012 | — |
| +2 | K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | 2026 | — |
| +2 | K251275 | VitalStream ART Connect; VitalStream-Hemo | Caretaker Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 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?
- Of its descendants, K181372 (Retia Medical, LLC, 2018) has gone furthest, with 2 descendants of its own.
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.
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 LiDCOplus Hemodynamic Monitor is intended for use as a diagnostic aid for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in patients greater than 881b (40kg) in weight.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023960: Lidcoplus Hemodynamic Monitor System, Model HM 70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023960
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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