# K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Witt Biomedical Corp
- Decided: Oct 26, 2010 after 144 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910772 (1991). 34 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063840: Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care Console and Central Station, Witt Biomedical Corp (2007) Summary page 1.
- K050093: Mac-Lab/Cardiolab EP/Combolab System, Ge Medical Systems Information Technologies (2005) Summary page 1.
- K040969: Poise Dataengine, Poise Technology Corporation (2004) Summary page 1.
- K020440: Newcor, Siemens Medical Systems, Inc. (2002) Summary page 1.
- K980688: Integriti Patient Monitor, Alliance Instruments (1999) Summary page 1.

## Most influential descendants
- K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own
- K241766: QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid) (2025), 0 descendants of its own
- K230881: Change Healthcare Cardiology Hemodynamics™ (2023), 0 descendants of its own
- K181311: Philips Hemodynamic Application R1.0 (2018), 0 descendants of its own

## Recalls of this device
- Mar 29, 2021 · Class II · Z-1517-2021: Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is ro
- Nov 15, 2018 · Class II · Z-0614-2019: There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In
- Sep 24, 2018 · Class II · Z-0462-2019: The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activ
- Aug 3, 2018 · Class II · Z-3192-2018: Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR
- Nov 20, 2017 · Class II · Z-2115-2018: While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window
- Aug 18, 2017 · Class II · Z-0263-2018: Intermittent communication between the host system and the FlexCardio
- Aug 11, 2017 · Class II · Z-0082-2018: Intermittent communication between the host system and the Flex Cardio
- Oct 19, 2015 · Class II · Z-2760-2016: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze

## Indications for use
The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring. The system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, pulse oximetry (SPO2), end tidal CO 2 (ETCO 2 ), fractional flow reserve (FER), non-invasive blood pressure (NIBP), surface body temperature and thermal cardiac output. The system also provides for clinical data acquisition, medical image/data processing, and analytical assessment. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may ffinction as a stand-alone device. The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic! hemodynarnic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired~ from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and ,may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system is capable of receiving and displaying user-adjustable alarms (both visual and audible) available in the system, which alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

Source page: https://510kreport.com/device/K101571
Methodology: https://510kreport.com/methodology