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Patient Status Engine

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172329

by Isansys Lifecare, Ltd.

Identifiers

510(k) Number
K172329 FDA 510(k)
FDA Product Code
DRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2910 FDA 510(k)
Regulation Number
870.2910 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Patient Status Engine is a wireless physiological signal transmitter and receiver system (Device Class II) designed for continuous monitoring of vital signs. It integrates wearable sensors with secure networking to provide real-time patient data transmission, supporting both acute and chronic care pathways in clinical settings.

The device is supplied as a configurable, wireless platform for use in hospitals, high-dependency units, general wards, or home environments. It operates as a reusable system with FDA 510(k) clearance and MDR compliance, requiring no sterilisation. Multiple sensor models (e.g., 3008717264, 3007134734) are compatible, and its radiofrequency-based operation adheres to regulatory standards (870.2910). No MRI safety classification is specified.

Frequently asked questions

What types of clinical environments is the Patient Status Engine designed to support, and how does its wireless functionality benefit these settings?

The Patient Status Engine is configured for use in hospitals, high-dependency units, general wards, and even home environments, making it versatile for both acute and chronic care pathways. Its wireless design eliminates the need for physical cables, reducing patient movement restrictions and enabling continuous, real-time monitoring without tethering. This is particularly useful in dynamic settings like wards or high-dependency units, where mobility and ease of use are critical.

Are the sensors compatible with the Patient Status Engine reusable, and if so, what does this mean for maintenance and cleaning?

Yes, the Patient Status Engine itself is a reusable system, and it supports multiple sensor models (e.g., 3008717264, 3007134734) that are also designed for reuse. Since no sterilization is required, maintenance involves routine cleaning and inspection to ensure sensor accuracy and system reliability. This approach reduces waste and operational costs while maintaining hygiene standards for continuous patient monitoring.

How many sensor models are compatible with the Patient Status Engine, and what does this flexibility allow clinicians to do?

The Patient Status Engine is compatible with over 70 distinct sensor models, as listed in the regulatory data (e.g., 3008717264, 3007134734, etc.). This extensive compatibility allows clinicians to select sensors tailored to specific patient needs—such as cardiac, respiratory, or peripheral monitoring—while ensuring seamless integration with the wireless transmitter and receiver system. It also simplifies inventory management by supporting a broad range of monitoring applications.

Does the Patient Status Engine require any special storage conditions, and how should it be handled between uses?

The Patient Status Engine is not specified to require sterilization or special storage conditions beyond standard environmental controls for medical devices. Since it is reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage to its wireless components and ensure long-term functionality. Proper handling—such as avoiding physical stress or exposure to liquids—is recommended to maintain performance and regulatory compliance.

What regulatory pathways does the Patient Status Engine follow, and how does this affect its adoption in clinical settings?

The Patient Status Engine has obtained FDA 510(k) clearance and MDR compliance, confirming its substantial equivalence to existing devices and adherence to European medical device regulations. This dual regulatory approval streamlines adoption in both U.S. and international markets, providing clinicians and healthcare facilities with confidence in its safety, performance, and compliance with global standards. The device’s classification as Class II also indicates it undergoes rigorous pre-market review for its intended use in continuous physiological monitoring.

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: Isansys.com, The PSE in use - Isansys.com, PDF Isansys Lifecare Limited

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Sources (2)

  • FDA 510(k) K172329 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026