# K133973: Tempus Pro with Enhanced Features

- Pathway: 510(k) (Abbreviated)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: Aug 14, 2014 after 231 days
- Product code: QYW (Hospital Cardiac Telemetry)
- 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: 32 generations back to K941811 (1994). 279 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 283 devices in its family (counting itself) has 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 6.
- K123074: Imec, Ipm and Beneview T1 Patient Monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 6.
- K101619: Welch Allyn 1500 Patient Monitor, Schiller AG (2010) Summary page 6.
- K131929: Surveyor Central Station, Mortara Instrument, Inc. (2013) Summary page 6.
- K120366: Intellivue Patient Monitor, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2012) Summary page 6.

## 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; 12 Lead ECG recording; real-time arrhythmia detection / alarming; QT measurement / alarming and ST measurements / alarming; 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/K133973
Methodology: https://510kreport.com/methodology