# K173768: Tempus Pro Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Jan 10, 2018 after 30 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: 34 generations back to K941811 (1994). 379 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 381 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170567: Tempus Pro Patient Monitor, Remote Diagnostic Technologies, Ltd. (2017) Summary page 5.

## Most influential descendants
- K201746: Tempus Pro Patient Monitor (2020), 0 descendants of its own

## Indications for use
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3 & 5 Lead ECG monitoring; 12 Lead ECG recording with interpretation; real-time arrhythmia detection / alarming; QT measurement / alarming and ST measurements / alarming; impedance pneumography; noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methaemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates. The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts / Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. These optional accessories are to be used in accordance with their Indications For Use.

Source page: https://510kreport.com/device/K173768
Methodology: https://510kreport.com/methodology