# K152006: Cogent Hemodynamic Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: May 5, 2016 after 289 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853018 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021874: Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711, Abbott Laboratories (2002) Summary page 4.
- K122247: Lidcorapid V2 Monitor, Lidco, Ltd. (2013) Summary page 4.

## Most influential descendants
- K232048: Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (2023), 0 descendants of its own

## Recalls of this device
- Nov 9, 2020 · Class II · Z-0859-2021: 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: 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: 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 displ
- Jan 5, 2018 · Class II · Z-1775-2018: 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.

## Indications for use
• 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.

Source page: https://510kreport.com/device/K152006
Methodology: https://510kreport.com/methodology