# K241766: QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid)

- Pathway: 510(k) (Traditional)
- Applicant: Fysicon BV
- Decided: Aug 27, 2025 after 433 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001305 (2000). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP, Fysicon BV (2017) Summary page 5.
- K131497: Mckesson Cardiology Hemo, Mckesson Israel, Ltd. (2013) Summary page 5.

## Indications for use
QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG. QMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment. QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology. QMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.

Source page: https://510kreport.com/device/K241766
Methodology: https://510kreport.com/methodology