# K082421: Heartsuite Hemodynamics 7.10

- Pathway: 510(k) (Traditional)
- Applicant: Emageon, Inc.
- Decided: Dec 17, 2008 after 117 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001305 (2000). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System, GE Healthcare (2006) Summary page 1.

## Most influential descendants
- K152864: Merge Hemo (2016), 1 descendant of its own
- K233326: Merge Hemo, Model RCSV2 (2024), 0 descendants of its own

## Recalls of this device
- Apr 4, 2016 · Class II · Z-1778-2017: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
- Apr 4, 2016 · Class II · Z-1457-2017: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
- Mar 28, 2016 · Class II · Z-1091-2017: There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
- Mar 10, 2016 · Class II · Z-2707-2017: If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by t
- Oct 26, 2015 · Class II · Z-0554-2016: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
- May 31, 2015 · Class II · Z-1203-2017: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
- Mar 30, 2015 · Class II · Z-1923-2017: The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added
- Jan 21, 2015 · Class II · Z-2347-2015: A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
- Sep 29, 2014 · Class II · Z-0143-2015: It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of 
- Apr 30, 2014 · Class II · Z-0665-2017: The application may crash during the cath lab procedure.
- Jul 2, 2012 · Class II · Z-2341-2016: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

## Indications for use
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal C02. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 1OV. The system is intended for use in hospital cardiac catheterization laboratories. The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class fla (RL 93/42/EWG, Appendix IX).

Source page: https://510kreport.com/device/K082421
Methodology: https://510kreport.com/methodology