# K161517: Mortara Surveyor Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Jan 11, 2017 after 223 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: 30 generations back to K941811 (1994). 248 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 250 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123556: Mortara Surveyor Patient Monitor, Mortara Instrument, Inc. (2013) Summary page 6.
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 6.

## Most influential descendants
- K173765: Surveyor Patient Monitor (2018), 0 descendants of its own

## Indications for use
The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the monitoring of the following parameters: • Non-invasive blood pressure • Impedance respiration • Invasive blood pressure • Temperature • Functional arterial oxygen saturation (SpO2) • End-tidal & inspired CO2 • ECG monitoring with arrhythmia & ST-segment • 12-Lead resting ECG • Cardiac output The Mortara Surveyor Patient Monitor is indicated for use in infants and neonatal patient populations for the monitoring of the following parameters: • Non-invasive blood pressure • Impedance respiration • Invasive blood pressure • Temperature • Functional arterial oxygen saturation (SpO2) • End-tidal & inspired CO2 • ECG monitoring with arrhythmia • 12-Lead resting ECG The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Source page: https://510kreport.com/device/K161517
Methodology: https://510kreport.com/methodology