# K141020: Surveyor S4 Mobile Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Dec 3, 2014 after 226 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933143 (1994). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974149: Ambulatory X-12 Telemetry Module, Mortara Instrument, Inc. (1998) Summary page 4.
- K081800: T12S Telemetry Transmitter, Mortara Instrument, Inc. (2008) Summary page 4.

## Most influential descendants
- K182297: Surveyor S2 (2019), 0 descendants of its own
- K160685: Surveyor S4 Mobile Monitor (2016), 0 descendants of its own

## Indications for use
The Surveyor S4 Mobile Monitor is indicated for use: • The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals. • The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. • The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data. • The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network. • The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.

Source page: https://510kreport.com/device/K141020
Methodology: https://510kreport.com/methodology