510(k) · Cleared
ClearedContinuous Cardiac Ouput Monitor, Truccom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Critical Care Limited · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jul 22, 2008 as substantially equivalent to K993245 (Alba Critical Care, Ltd., 1999) after a 29-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jul 22, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925444 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK925444 Cardiac Output Pulmonary Artery Catheter & MonitorAmi-Med Corp. · 1993
- 1 generation backK993245 Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath…Alba Critical Care, Ltd. · 1999
- This deviceK081776 Continuous Cardiac Ouput Monitor, TruccomOmega Critical Care Limited · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925444 | Cardiac Output Pulmonary Artery Catheter & Monitor | Ami-Med Corp. | 1993 | — |
| −1 | K993245 | Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous… | Alba Critical Care, Ltd. | 1999 | — |
| 0 (this device) | K081776 | Continuous Cardiac Ouput Monitor, Truccom | Omega Critical Care Limited | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K993245 | Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac…Summary page 1…Continuous Output Pulmonary Artery Catheter and Continuous Outout Monitor, 510(k) number K993245 Omega Critical Care Special 510(k): Device Modification Device Description: The Continuous C… | 1999 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
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. 2008, 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 Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor systems intended use is for the assessment of a patients haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081776: Continuous Cardiac Ouput Monitor, Truccom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081776
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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