# K134014: Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Aug 12, 2014 after 225 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935595 (1995). 98 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130773: Tempus Pro Patient Monitor, Remote Diagnostic Technologies, Ltd. (2013) Summary page 5.
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 5.
- K102153: Mobius Ultrasound Imaging System, Mobisante, Inc. (2011) Summary page 5.

## Most influential descendants
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own
- 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 and 12 Lead ECG recording, impedance pneumography, non-invasive blood pressure (NIBP), end-tidal CO2 (ETCO2) and respiration rate, pulse oximetry (SpO2), contact temperature and invasive pressure. 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/K134014
Methodology: https://510kreport.com/methodology