# K232048: Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical
- Decided: Dec 20, 2023 after 163 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K853018 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152006: Cogent Hemodynamic Monitoring System, Icu Medical, Inc. (2016) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K232048
Methodology: https://510kreport.com/methodology