# K033030: Calysto Series IV Patient Care Monitors and Central Station and Ecg Management System

- Pathway: 510(k) (Traditional)
- Applicant: Witt Biomedical Corp
- Decided: Feb 24, 2004 after 151 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063840: Xper Information Management/Physiomonitoring 5 System and/or Vascular 5, Patient Care Console and Central Station (2007), 6 descendants of its own
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own
- 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

## Recalls of this device
- Sep 16, 2005 · Not classified · Z-0305-06: Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.

## Indications for use
The CALYSTO Series IV is intended for complete physiologic/hemodynamic invasive monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, the data radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Series IV ECG Management system is intended for receiving is stored, resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Source page: https://510kreport.com/device/K033030
Methodology: https://510kreport.com/methodology