# K152864: Merge Hemo

- Pathway: 510(k) (Traditional)
- Applicant: Merge Healthcare Incorporated
- Decided: Apr 7, 2016 after 190 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001305 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130626: Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and Electrophys, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 4.
- K082421: Heartsuite Hemodynamics 7.10, Emageon, Inc. (2008) Summary page 4.

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

## Recalls of this device
- Jul 23, 2021 · Class II · Z-2387-2021: The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
- Apr 6, 2017 · Class II · Z-0350-2018: Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.

## Indications for use
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure, The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform. The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface, All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions. Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third party database the Hemo system can display drug to drug or drug to allergy interaction information. The system is intended for use in hospital cardiac catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.

Source page: https://510kreport.com/device/K152864
Methodology: https://510kreport.com/methodology