# Patient Status Engine

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/patient-status-engine-drg>
- Manufacturer: [Isansys Lifecare, Ltd.](https://devicerts.com/manufacturers/isansys-lifecare-ltd) (United Kingdom)
- Device class: Class II (US FDA)
- FDA product code: DRG

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K172329 · decision 2018-04-23 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K172329 [FDA 510(k)]
- FDA product code: DRG [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.2910 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Patient Status Engine, Isansys Lifecare, Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/patient-status-engine-drg (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/patient-status-engine-drg.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/patient-status-engine-drg
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.