# K123556: Mortara Surveyor Patient Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Mar 22, 2013 after 123 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962603 (1997). 80 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software, Spacelabs Healthcare Medical Equipment (Suzhou) CO (2009) Summary page 1.
- K060135: Mortara Surveyor Telemetry Central Station, Mortara Instrument, Inc. (2006) Summary page 1.
- K100127: Eli 230 Electrocardiograph, Mortara Instrument, Inc. (2010) Summary page 1.
- K012226: Monitoring System,Model Argus PB-1000, Schiller AG (2002) Summary page 1.

## Most influential descendants
- K161517: Mortara Surveyor Patient Monitor (2017), 1 descendant of its own
- K173765: Surveyor Patient Monitor (2018), 0 descendants of its own

## Recalls of this device
- Oct 7, 2014 · Class II · Z-0110-2015: Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors 

## Indications for use
The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of: * Non-invasive blood pressure * Impedance respiration * Invasive blood pressure * Temperature * Functional arterial oxygen saturation (SP02) * End-tidal & inspired 002 * ECG monitoring with arrhythmia & ST-segment * 12-Lead resting EG * Cardiac output 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/K123556
Methodology: https://510kreport.com/methodology