# K980688: Integriti Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Instruments
- Decided: Mar 16, 1999 after 386 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- 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
- K230881: Change Healthcare Cardiology Hemodynamics™ (2023), 0 descendants of its own

## Indications for use
The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.

Source page: https://510kreport.com/device/K980688
Methodology: https://510kreport.com/methodology