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Tempus Pro Patient Monitor

by Remote Diagnostic Technologies Ltd. 3 variants

510(k) K130773

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K130773; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130773↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130773 Date5 Jun 2013ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1666-2025 FDA Class II initiated 16 Apr 2025 on shared 510(k) K130773

    software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
FDA applicant
Remote Diagnostic Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tempus Pro Patient Monitor is a Patient Monitoring Device designed to continuously track and display vital signs such as heart rate, blood pressure, oxygen saturation, and electrocardiogram (ECG) readings. It provides real-time physiological data to support clinical decision-making in acute and critical care settings, ensuring timely intervention when abnormalities are detected.

This device is intended for use in hospital environments, including intensive care units (ICUs) and emergency departments, where continuous patient monitoring is essential. Supplied as a reusable medical device, it requires proper cleaning and maintenance between uses to ensure sterility and functionality. The Tempus Pro Patient Monitor is authorised under FDA 510K and MDD, adhering to regulatory standards for cardiovascular monitoring equipment. Its design includes standardised connectors and display interfaces for compatibility with hospital infrastructure.

Other devices from Remote Diagnostic Technologies Limited

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Tempus Pro Patient Monitor designed for single-use or reusable in clinical settings, and what maintenance is required between uses?

    The Tempus Pro Patient Monitor is a reusable device, meaning it is intended for repeated use across multiple patients. Since it is reusable, it requires proper cleaning and maintenance between uses to ensure sterility and functionality. The manufacturer emphasizes adherence to cleaning protocols to maintain its performance and compliance with regulatory standards for cardiovascular monitoring equipment.

  • What types of vital signs does the Tempus Pro Patient Monitor track, and where is it primarily intended for use?

    The Tempus Pro Patient Monitor continuously tracks and displays heart rate, blood pressure, oxygen saturation (SpO₂), and electrocardiogram (ECG) readings. It is specifically designed for use in hospital environments, including intensive care units (ICUs) and emergency departments, where continuous patient monitoring is critical for clinical decision-making and timely interventions.

  • How does the Tempus Pro Patient Monitor integrate with hospital systems, and what regulatory pathways does it follow?

    The device features standardized connectors and display interfaces, ensuring compatibility with existing hospital infrastructure for seamless integration. Regulatory-wise, the Tempus Pro Patient Monitor follows the FDA 510K pathway (with a Traditional clearance type and substantially equivalent determination) and complies with the Medical Devices Directive (MDD) in Europe, adhering to standards for cardiovascular monitoring equipment.

  • What clinical settings is the Tempus Pro Patient Monitor most commonly used in, and why?

    The Tempus Pro Patient Monitor is most commonly used in acute and critical care settings, such as ICUs and emergency departments, where continuous patient monitoring is essential. Its real-time physiological data support timely clinical interventions when abnormalities are detected, making it ideal for high-acuity environments where patient stability is paramount.