# K173765: Surveyor Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Sep 4, 2018 after 267 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 37 generations back to K941811 (1994). 303 ancestors in all.
No later device cites it as a predicate yet.
1 of 304 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161517: Mortara Surveyor Patient Monitor, Mortara Instrument, Inc. (2017) Summary page 6.
- K161531: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800, Philips Medizin Systeme Boeblingen GmbH (2016) Summary page 6.

## Recalls of this device
- Mar 31, 2021 · Class II · Z-1484-2021: Devices do not meet IEC 60601-2-27 requirements as labeled.
- Mar 18, 2020 · Class II · Z-1816-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## 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 ‘Bed to Bed communication’ feature allows remote viewing of monitors when connected to a Surveyor Central Station. 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/K173765
Methodology: https://510kreport.com/methodology