# K133988: Tempus Pro Extended Features

- Pathway: 510(k) (Abbreviated)
- Applicant: Remote Diagnostic Technologies, Ltd.
- Decided: May 16, 2014 after 141 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: 14 generations back to K962603 (1997). 60 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 64 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 2.
- K130773: Tempus Pro Patient Monitor, Remote Diagnostic Technologies, Ltd. (2013) Summary page 2.
- K083749: CARDIOVIEW32 Review Module, Qrs Diagnostic, LLC (2009) Summary page 2.

## 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 partable 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 with Interpretation, impedance pneumography, non-Invasive blood pressure (NIBP), end-tidal C02 (ETCO2), respiration rate, pulse oximetry (Spa2), contact temperature, invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), metheglobin (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, pediatrics and neonates.

Source page: https://510kreport.com/device/K133988
Methodology: https://510kreport.com/methodology