# K141811: Mortara Monitoring Waveform Viewer

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Nov 19, 2014 after 135 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites 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)
- K131929: Surveyor Central Station, Mortara Instrument, Inc. (2013) Summary page 4.

## Most influential descendants
- K222586: Mural Clinical Viewer (2022), 0 descendants of its own

## Indications for use
The Monitoring Waveform Viewer is indicated for use as follows: The Monitoring Waveform Viewer is a software component utilized within another software application. The Monitoring Waveform Viewer performs the following: • Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters. • Display of reported alarm states produced by such monitoring systems. • Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon. • Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waveform Viewer displays still waveforms. • Provide selected waveform episodes to the host application for printing or inclusion in the patient record. The Monitoring Waveform Viewer: • Is not a primary or secondary alarm device. • Does not provide a user interface for acknowledging or silencing active alarms. • Does not generate audible or visual (flashing) notifications of active alarms. The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

Source page: https://510kreport.com/device/K141811
Methodology: https://510kreport.com/methodology