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Patient Status Engine

by Isansys Lifecare, Ltd.

510(k) K172329

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172329↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172329 Date23 Apr 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172329 decided 23 Apr 2018 Active
  • EUDAMED Active

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DRG
Device class
Class II
Regulation
21 CFR Part 870.2910
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 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.

Devices cleared under K172329

16 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K172329
UDI-DISize and differences
Isansys Lifeguard Server
ISANSYS LIFECARE LIMITED
Lifeguard Server / Lifeguard Server05060488680175
Prescription: no; Single use: no
On the market
Isansys Lifetemp Sensor - Large
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Large / Lifetemp Sensor - Large05060488680038
Prescription: yes; Single use: yes
On the market
Isansys Lifetemp Sensor - Medium
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Medium / Lifetemp Sensor - Medium05060488680021
Prescription: yes; Single use: yes
On the market
Isansys Lifetemp Sensor - Small
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - Small / Lifetemp Sensor - Small05060488680014
Prescription: yes; Single use: yes
On the market
Isansys Lifetemp Sensor - V2 - Large
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large / Lifetemp Sensor - V2 - Large05060488680298
Prescription: yes; Single use: yes
On the market
Isansys Lifetemp Sensor - V2 - Large
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Large / Lifetemp Sensor - V2 - Large05060488680274
Prescription: yes; Single use: yes
On the market
Isansys Lifetemp Sensor - V2 - Medium
ISANSYS LIFECARE LIMITED
Lifetemp Sensor - V2 - Medium / Lifetemp Sensor - V2 - Medium05060488680281
Prescription: yes; Single use: yes
On the market
Isansys Lifetouch Sensor - Large
ISANSYS LIFECARE LIMITED
Lifetouch Sensor - Large / Lifetouch Sensor - Large05060488680113
Prescription: yes; Single use: yes
On the market
Isansys Lifetouch Sensor - Medium
ISANSYS LIFECARE LIMITED
Lifetouch Sensor - Medium / Lifetouch Sensor - Medium05060488680106
Prescription: yes; Single use: yes
On the market
Isansys Lifetouch Sensor - Small
ISANSYS LIFECARE LIMITED
Lifetouch Sensor - Small / Lifetouch Sensor - Small05060488680090
Prescription: yes; Single use: yes
On the market
Isansys Patient Gateway SM-X200 – 10.5 - WiFi
ISANSYS LIFECARE LIMITED
Gateway SM-X200 – 10.5 - WiFi / Patient Gateway SM-X200 – 10.5 - WiFi05060488680304
Prescription: yes; Single use: no
On the market
Isansys Patient Gateway T510 - 10.1 - WiFi
ISANSYS LIFECARE LIMITED
Gateway T510 - 10.1 - WiFi / Patient Gateway T510 - 10.1 - WiFi05060488680250
Prescription: yes; Single use: no
On the market
Isansys Patient Gateway T515 - 10.1 - GSM
ISANSYS LIFECARE LIMITED
Gateway T515 - 10.1 - GSM / Patient Gateway T515 - 10.1 - GSM05060488680267
Prescription: yes; Single use: no
On the market
Isansys Patient Gateway T580 - 10.1 - GSM
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - GSM / Patient Gateway T580 - 10.1 - GSM05060488680205
Prescription: yes; Single use: no
On the market
Isansys Patient Gateway T580 - 10.1 - WiFi
ISANSYS LIFECARE LIMITED
Gateway T580 - 10.1 - WiFi / Patient Gateway T580 - 10.1 - WiFi05060488680182
Prescription: yes; Single use: no
On the market
Patient Gateway SM-X205 - 10.5 Screen - GSM
ISANSYS LIFECARE LIMITED
Gateway SM-X205 GSM / SM-X205 - 10.5 Screen - GSM05060488680311
Prescription: yes; Single use: no
On the market

Similar devices

Other devices filed under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

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