510(k) · Cleared
ClearedCogent™ Hemodynamic Monitoring System; Cogent™ HMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Dec 20, 2023 as substantially equivalent to K152006 (Icu Medical, Inc., 2016) after a 163-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Dec 20, 2023
- Review
- 163 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853018 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK853018 Model 3000 Opticath ComputerOximetrix, Inc. · 1986 · Recalled
- 2 generations backK021874 Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number…Abbott Laboratories · 2002
- 1 generation backK152006 Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016 · Recalled
- This deviceK232048 Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853018 | Model 3000 Opticath Computer | Oximetrix, Inc. | 1986 | 2 |
| −2 | K021874 | Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711 | Abbott Laboratories | 2002 | — |
| −1 | K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016 | 4 |
| 0 (this device) | K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K152006 | Cogent Hemodynamic Monitoring SystemSummary page 5…DXG - Computer, Diagnostic, Pre-Programmed, Single-Function; DQA - Oximeter Legally marketed device(s) to K152006, Cogent™ Hemodynamic Monitoring System (ICU which equivalence s claimed Medical) with software version 1.1.8 III. Re… | 2016 |
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 37 years and passes through 4 companies; a new generation was cleared every 13.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
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. 2023, 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 Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to…
Read the full statement (218 words)
The Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients.
Target Population -
The target populations are critical care patients, trauma patients, and cardiac surgery patients. The Cogent HMS is restricted to one patient at a time, and the PulseCO functionality is limited to adult patients. There are no specific contraindications for the instrument. Suitability for use on a patient is up to the physician's judgment. The physician shall also decide on the diameter of the catheter to be used in conjunction with the Cogent HMS.
Environments for Use -
The Cogent HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and emergency units, coronary and intensive care units, and cardiac catheterization laboratories. The intended environment for use is the hospital, including the critical care units (i.e. medical, surgical, coronary), trauma and accident emergency units, post-anesthesia care units, operating rooms, and cardiac catheterization labs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232048: Cogent™ Hemodynamic Monitoring System; Cogent™ HMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232048
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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