510(k) · Cleared
Recalled · Class II · 2021Xper Information Management and Flex Cardio Physiomonitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Witt Biomedical Corp · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 26, 2010 as substantially equivalent to K063840 (Witt Biomedical Corp, 2007) and 4 other predicates after a 144-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 26, 2010
- Review
- 144 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 8
- Predicates
- 5
Its longest line of descent runs back 5 generations to K910772 (1991). 34 ancestors in all, the oldest K862740 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 4 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
- This deviceK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010
- Descendant · cites it directly · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- Descendant · 2 generations on · 0 of its ownK241766 QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025
- Descendant · 2 generations on · 0 of its ownK230881 Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK181311 Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V. · 2018 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · cites it directly3descendants
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 2 generations on1descendant
- K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025 · 2 generations on0descendants
- K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · 2 generations on0descendants
- K181311Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −4 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | 10 |
| 0 (this device) | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | — |
| +1 | K131497 | Mckesson Cardiology Hemo | Mckesson Israel, Ltd. | 2013 | 10 |
| +2 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| +2 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025 | — |
| +2 | K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel, Ltd. | 2023 | 2 |
| +1 | K181311 | Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063840 | Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care…Summary page 1…ation system) Computer, Diagnostic, Programmable Class II Predicate Device(s): Xper Information Management Sy~tem- K063840 GE Mactab/CardioLab EP/ComboLab System- K050093 Poise DataEngine- K040969… | 2007 |
| * | K050093 | Mac-Lab/Cardiolab EP/Combolab SystemSummary page 1…Class II Predicate Device(s): Xper Information Management Sy~tem- K063840 GE Mactab/CardioLab EP/ComboLab System- K050093 Poise DataEngine- K040969 Siemens AXIOM Sensis- K020440… | 2005 |
| * | K040969 | Poise DataengineSummary page 1…ce(s): Xper Information Management Sy~tem- K063840 GE Mactab/CardioLab EP/ComboLab System- K050093 Poise DataEngine- K040969 Siemens AXIOM Sensis- K020440 Alliance Instruments Integrity Patient Monitor- K… | 2004 |
| * | K020440 | NewcorSummary page 1…GE Mactab/CardioLab EP/ComboLab System- K050093 Poise DataEngine- K040969 Siemens AXIOM Sensis- K020440 Alliance Instruments Integrity Patient Monitor- K980688 Philips Xper Flex Cardio Physiomonitoring Sy… | 2002 |
| * | K980688 | Integriti Patient MonitorSummary page 1…Poise DataEngine- K040969 Siemens AXIOM Sensis- K020440 Alliance Instruments Integrity Patient Monitor- K980688 Philips Xper Flex Cardio Physiomonitoring System /Xper Information Management System Traditional 5 10(k)… | 1999 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2021 | Class II | Z-1517-2021 | Software design | 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 rounded to the nearest whole… |
| Nov 15, 2018 | Class II | Z-0614-2019 | Software Design Change | 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 auto cycle mode, if the NIBP… |
| Sep 24, 2018 | Class II | Z-0462-2019 | Software Design Change | 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, activate or deactivate the mean pressure… |
| Aug 3, 2018 | Class II | Z-3192-2018 | Software Manufacturing/Software Deployment | 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) displayed due to QRS detection fault. |
| Nov 20, 2017 | Class II | Z-2115-2018 | Software design | 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 | Software Design Change | Intermittent communication between the host system and the FlexCardio |
| Aug 11, 2017 | Class II | Z-0082-2018 | Software Design Change | Intermittent communication between the host system and the Flex Cardio |
| Oct 19, 2015 | Class II | Z-2760-2016 | Unknown/Undetermined by firm | Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K131497 (Mckesson Israel, Ltd., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (450 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101571
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026