Identifiers
- 510(k) Number
- K201746 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tempus Pro Patient Monitor is a physiological patient monitoring device designed for the detection and alarming of arrhythmias. It falls under the category of monitors intended for continuous assessment of cardiac function, providing real-time monitoring of vital signs in clinical settings.
This device is supplied in both printer and non-printer configurations, with hardware versions ranging from 00-1007-R to 00-1026-R, and is compatible with software versions 4.40 and 7.40. It is classified as a Class II medical device under FDA regulations (21 CFR 870.1025) and holds a Special 510(k) clearance with a K-number of K201746. The device is intended for use in healthcare environments, though specific sterility or single-use/reusable status is not detailed in the provided data.
Frequently asked questions
What clinical scenarios is the Tempus Pro Patient Monitor primarily designed to address within a healthcare setting?
The Tempus Pro Patient Monitor is specifically designed for the continuous assessment of cardiac function, with a focus on detecting and alarming arrhythmias. This makes it particularly useful in clinical environments where real-time monitoring of heart rhythms is critical, such as intensive care units, emergency rooms, or during surgical procedures where cardiac stability is a priority.
Does the Tempus Pro Patient Monitor come with printing capabilities, and if so, how does this feature affect its versatility?
Yes, the Tempus Pro Patient Monitor is available in both printer and non-printer configurations. The printer version allows for immediate hard-copy recording of vital signs and arrhythmia events, which can be critical for documentation and immediate review by clinicians. This feature enhances its versatility in settings where printed records are required for patient charts or regulatory compliance.
What software versions are compatible with the Tempus Pro Patient Monitor, and how might this affect my upgrade or maintenance plans?
The Tempus Pro Patient Monitor is compatible with software versions 4.40 and 7.40. When planning for upgrades or maintenance, ensure your device is running a supported software version to maintain functionality, access to updates, and compatibility with any future firmware or hardware revisions. Always verify with the manufacturer if newer versions are available.
Is the Tempus Pro Patient Monitor intended for single-use or reusable applications, and what does this mean for my facility’s infection control protocols?
The provided data does not specify whether the Tempus Pro Patient Monitor is single-use or reusable. However, as it is a Class II medical device used for continuous monitoring in clinical settings, it is likely designed for reusable applications with appropriate cleaning and sterilization protocols. Facilities should consult the manufacturer’s guidelines for proper disinfection and maintenance procedures to ensure patient safety and device longevity.
What regulatory pathway was followed for the FDA clearance of the Tempus Pro Patient Monitor, and what does this imply about its safety and effectiveness?
The Tempus Pro Patient Monitor received a Special 510(k) clearance (K201746) under the FDA’s premarket notification process, which means it was determined to be substantially equivalent to a legally marketed device. This clearance implies that the manufacturer has demonstrated that the device meets FDA safety and performance standards for its intended use in detecting and alarming arrhythmias. The classification as a Class II device also indicates it is subject to additional controls beyond general controls.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Tempus Pro User/Operator Manual - heartstream.com, MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. Tempus ..., PDF Tempus Pro User/Operator Manual - documents.philips.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201746 | Class II | Active |
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Manufacturer
- Manufacturer
- Remote Diagnostic Technologies Limited
Sources (1)
- FDA 510(k) K201746 24 fields · synced Sep 19, 2026