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Tempus Pro Patient Monitor

by Remote Diagnostic Technologies Ltd. 3 variants

510(k) K170567

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

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170567↗

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 NumberK170567 Date6 Jul 2017ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
MHX
FDA applicant
Remote Diagnostic Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1025
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 physiological patient monitoring device designed for continuous assessment of vital signs, including arrhythmia detection and alarm capabilities. It falls under the category of monitors for cardiovascular applications, providing real-time monitoring of heart rhythm and other critical parameters to support clinical decision-making in acute care settings.

This device is intended for use in clinical environments such as hospitals and intensive care units, where real-time patient monitoring is essential. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDD regulatory standards. The monitor is classified under device class 2 and is authorised for use in cardiovascular applications, with specific regulatory filings under the OpenFDA system. No information regarding single-use or MRI safety is provided in the specifications.

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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 can it be reused in clinical settings?

    The Tempus Pro Patient Monitor is explicitly described as a reusable medical device. Since it is intended for continuous monitoring in acute care environments like hospitals and intensive care units, it is engineered to withstand repeated use after proper cleaning and maintenance, rather than being intended for single-use.

  • What types of vital signs and clinical features does the Tempus Pro Patient Monitor provide, and where is it primarily used?

    The Tempus Pro Patient Monitor is designed for continuous assessment of vital signs, with a specific focus on heart rhythm monitoring, including arrhythmia detection and alarm capabilities. It is intended for use in clinical environments such as hospitals and intensive care units, where real-time cardiovascular monitoring is critical for clinical decision-making.

  • How is the regulatory approval process for the Tempus Pro Patient Monitor structured, and what does this imply for its use?

    The Tempus Pro Patient Monitor has been authorized through FDA 510(k) clearance and MDD (Medical Device Directive) compliance, indicating it meets regulatory standards for substantially equivalent devices in the cardiovascular category. This approval route implies it has undergone rigorous evaluation for safety and performance, ensuring its suitability for real-time patient monitoring in acute care settings as described.

  • Does the Tempus Pro Patient Monitor come with multiple models or configurations, and if so, how are they differentiated?

    The provided data lists multiple FEI (Facility Establishment Identifier) numbers and registration numbers, which typically correspond to different facility-specific configurations or serial ranges rather than distinct physical models. However, no explicit details on size variations, software versions, or hardware configurations are provided. Clinicians should confirm with the manufacturer whether specific models or configurations are available for their needs.

  • What should clinicians consider regarding storage and maintenance of the Tempus Pro Patient Monitor?

    While the data does not specify storage conditions or maintenance protocols, the device is reusable, meaning it requires proper cleaning, calibration, and maintenance between uses to ensure accuracy and reliability. Clinicians should follow the manufacturer’s guidelines (available from Remote Diagnostic Technologies Ltd.) for storage, sanitization, and routine upkeep to comply with clinical and regulatory standards.