# K160685: Surveyor S4 Mobile Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Aug 4, 2016 after 146 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: 6 generations back to K933143 (1994). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141020: Surveyor S4 Mobile Monitor, Mortara Instrument, Inc. (2014) Summary page 5.
- K080251: Apexpro Telemetry Systems, Ge Medical Systems Information Technologies (2008) Summary page 5.

## Recalls of this device
- Mar 18, 2020 · Class II · Z-1815-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The Surveyor S4 Mobile Monitor is indicated for use: The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own. The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station. The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure. The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children. The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

Source page: https://510kreport.com/device/K160685
Methodology: https://510kreport.com/methodology