510(k) · Cleared
ClearedContinous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alba Critical Care, Ltd. · DYG Catheter, Flow Directed
Cleared on Oct 28, 1999 as substantially equivalent to K925444 (Ami-Med Corp., 1993) after a 30-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 28, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925444 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK925444 Cardiac Output Pulmonary Artery Catheter & MonitorAmi-Med Corp. · 1993
- This deviceK993245 Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath…Alba Critical Care, Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK081776 Continuous Cardiac Ouput Monitor, TruccomOmega Critical Care Limited · 2008
Most influential descendants
Showing 1 of 1 · See all- K081776Continuous Cardiac Ouput Monitor, TruccomOmega Critical Care Limited · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925444 | Cardiac Output Pulmonary Artery Catheter & Monitor | Ami-Med Corp. | 1993 | — |
| 0 (this device) | K993245 | Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous… | Alba Critical Care, Ltd. | 1999 | — |
| +1 | K081776 | Continuous Cardiac Ouput Monitor, Truccom | Omega Critical Care Limited | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 DYG? 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 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 |
|---|---|---|---|
| * | K925444 | Cardiac Output Pulmonary Artery Catheter & MonitorSummary page 1…e is substantially equivalent to the previously cleared Ami-MED Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor, 51 0(k) number K925444 The Continuous Cardiac Output Pulmonary Artery Catheter, (catalogue # TruCATH), is a six-lumen, heparin-coated, polyvinyl chlori… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081776 | Continuous Cardiac Ouput Monitor, Truccom | 2008 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K081776 (Omega Critical Care Limited, 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system’s intended use is for the assessment of a patient’s 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993245 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993245: Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993245
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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