# K131497: Mckesson Cardiology Hemo

- Pathway: 510(k) (Traditional)
- Applicant: Mckesson Israel, Ltd.
- Decided: Dec 5, 2013 after 195 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 10 (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). 38 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050561: Windsurfer, Medcon, Ltd. (2005) Summary page 1.
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems, Witt Biomedical Corp (2010) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- May 22, 2025 · Class II · Z-2071-2025: Due to complaints, software update may cause software to unexpectedly shutdown.
- Dec 2, 2024 · Class II · Z-0957-2025: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
- Dec 2, 2024 · Class II · Z-0958-2025: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
- Aug 21, 2024 · Class II · Z-0128-2025: A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappro
- Aug 21, 2024 · Class II · Z-0126-2025: A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappro
- Mar 25, 2019 · Class II · Z-1490-2019: users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepan
- Mar 25, 2019 · Class II · Z-1489-2019: users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepan
- Mar 12, 2018 · Class II · Z-2968-2018: Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.
- Aug 27, 2014 · Class II · Z-0042-2015: Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
- Jun 25, 2014 · Class II · Z-0093-2015: McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a para

## Indications for use
McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also 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 sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. McKesson Cardiology Hemo is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed. 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 for unattended patient monitoring or in situations where arrhythmia detection is required.

Source page: https://510kreport.com/device/K131497
Methodology: https://510kreport.com/methodology