# K201746: Tempus Pro Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Remote Diagnostic Technologies Limited
- Decided: Sep 18, 2020 after 84 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 35 generations back to K941811 (1994). 401 ancestors in all.
No later device cites it as a predicate yet.
1 of 402 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173768: Tempus Pro Patient Monitor, Remote Diagnostic Technologies, Ltd. (2018) Summary page 5.
- K151860: Infinity CentralStation Wide, Draeger Medical Systems, Inc. (2015) Summary page 5.

## Recalls of this device
- Nov 26, 2025 · Class II · Z-1027-2026: Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgm
- May 30, 2025 · Class II · Z-2175-2025: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), 
- 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.
- Apr 15, 2025 · Class II · Z-1729-2025: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or 
- Aug 24, 2023 · Class II · Z-2625-2023: Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/resta
- Feb 23, 2023 · Class II · Z-1321-2023: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
- May 25, 2021 · Class II · Z-1997-2021: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

## 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-, 4- and 5-lead ECG monitoring; 12-lead ECG recording with interpretation; 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 and extended pulse oximetry capability including; carboxyhaemoglobin (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/K201746
Methodology: https://510kreport.com/methodology