# K181311: Philips Hemodynamic Application R1.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederlands B.V.
- Decided: Sep 7, 2018 after 113 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 6 generations back to K910772 (1991). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems, Witt Biomedical Corp (2010) Summary page 4.

## Recalls of this device
- May 2, 2024 · Class II · Z-1926-2024: Potential for pressure wave data synchronization from two devices may not be correct.
- Feb 22, 2022 · Class II · Z-1041-2022: When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inf

## Indications for use
The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. The software may be used to display and/or analyze surface Electrocardiogram (ECG), Respiration, Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output. The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices. Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet. The software is indicated for use in the following areas: (interventional) cardiology, electrophysiology and radiology. The Philips Hemodynamic Application is indicated for use for all human patients of all ages.

Source page: https://510kreport.com/device/K181311
Methodology: https://510kreport.com/methodology