# K130773: Tempus Pro Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Jun 5, 2013 after 77 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 5 generations back to K962603 (1997). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101264: Tempus IC Professional Patient Monitor, Remote Diagnostic Technologies, Ltd. (2010) Summary page 3.
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 3.

## Most influential descendants
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K134014: Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe) (2014), 3 descendants of its own
- K133988: Tempus Pro Extended Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own

## Recalls of this device
- Apr 16, 2025 · Class II · Z-1666-2025: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

## 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.

Source page: https://510kreport.com/device/K130773
Methodology: https://510kreport.com/methodology