510(k) · Cleared
Recalled · Class II · 2020Cogent Hemodynamic Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · DXQ Blood Pressure Cuff
Cleared on May 5, 2016 as substantially equivalent to K021874 (Abbott Laboratories, 2002) and 1 other predicate after a 289-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it. It has been recalled 4 times.
- Decided
- May 5, 2016
- Review
- 289 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853018 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK853018 Model 3000 Opticath ComputerOximetrix, Inc. · 1986 · Recalled
- 1 generation backK021874 Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number…Abbott Laboratories · 2002
- This deviceK152006 Cogent Hemodynamic Monitoring SystemIcu Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK232048 Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853018 | Model 3000 Opticath Computer | Oximetrix, Inc. | 1986 | 2 |
| −1 | K021874 | Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711 | Abbott Laboratories | 2002 | — |
| 0 (this device) | K152006 | Cogent Hemodynamic Monitoring System | Icu Medical, Inc. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 DXQ? 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 DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 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 |
|---|---|---|---|
| * | K021874 | Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711Summary page 4…Regulatory Class: II Product Code: DXG and DQA 3 Predicate Devices Primary predicate: Abbott Q2 Plus SO2/Continuous Cardiac Output Computer, K021874 Secondary predicate: LiDCOrapid Hemodynamic Monitor, K122247 These predicates have not been subjected to a design-related recall.… | 2002 |
| * | K122247 | Lidcorapid V2 MonitorSummary page 4…DXG and DQA 3 Predicate Devices Primary predicate: Abbott Q2 Plus SO2/Continuous Cardiac Output Computer, K021874 Secondary predicate: LiDCOrapid Hemodynamic Monitor, K122247 These predicates have not been subjected to a design-related recall. 4 Device Description The CogentTM HMS system is designed to… | 2013 |
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 |
|---|---|---|---|
| K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2020 | Class II | Z-0859-2021 | Software design | Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. |
| Feb 14, 2020 | Class II | Z-1927-2020 | Software Design Change | Firm identified software issues which leads to the patient ID and patient information not being stored in the system. |
| Jul 12, 2019 | Class II | Z-1835-2020 | Under Investigation by firm | Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter. |
| Jan 5, 2018 | Class II | Z-1775-2018 | Software design | When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 16.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K232048 (Icu Medical, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
• The Cogent™ Hemodynamic Monitoring System (HMS) is intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Suitability for use on a patient is up to the physician’s judgment and the diameter of the catheter to be used. • The target population includes patients for whom hemodynamic monitoring will improve clinical care. The…
Read the full statement (223 words)
• The Cogent™ Hemodynamic Monitoring System (HMS) is intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Suitability for use on a patient is up to the physician’s judgment and the diameter of the catheter to be used.
• The target population includes patients for whom hemodynamic monitoring will improve clinical care. The target populations are identical to those for the predicate devices and include:
o Critical Care Patients
o Trauma Patients
o Cardiac Surgery Patients
• 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
• The intended environment for use is the hospital including Critical Care Units (such as Medical, Surgical, and Coronary), Trauma and Accident Emergency Units, Post Anesthesia Care Units, Operating Rooms, and Cardiac Catheterization labs.
• The Cogent™ HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories.
• The Cogent™ HMS is restricted to one patient at a time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152006: Cogent Hemodynamic Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152006
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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