# K233326: Merge Hemo, Model RCSV2

- Pathway: 510(k) (Traditional)
- Applicant: Merge Healthcare Incorporated
- Decided: Jun 21, 2024 after 266 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001305 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152864: Merge Hemo, Merge Healthcare Incorporated (2016) Summary page 6.

## Recalls of this device
- Aug 11, 2025 · Class II · Z-2518-2025: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge He

## Indications for use
Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures. The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO, 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 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 (EtCO,) along with apnea and respiration rates calculated from the EtCO, waveforms. The system can also perform specified calculations from captured or manually entered values. The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses. 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 Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K233326
Methodology: https://510kreport.com/methodology