# K230881: Change Healthcare Cardiology Hemodynamics™

- Pathway: 510(k) (Traditional)
- Applicant: Change Healthcare Israel, Ltd.
- Decided: Sep 11, 2023 after 165 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: 7 generations back to K910772 (1991). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131497: Mckesson Cardiology Hemo, Mckesson Israel, Ltd. (2013) Summary page 5.

## Recalls of this device
- May 22, 2025 · Class II · Z-2072-2025: Due to complaints, software update may cause software to unexpectedly shutdown.
- Dec 2, 2024 · Class II · Z-0959-2025: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

## Indications for use
Change Healthcare Cardiology Hemodynamics™ is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Change Healthcare Cardiology Hemodynamics™ 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. Change Healthcare Cardiology Hemodynamics™ 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/K230881
Methodology: https://510kreport.com/methodology