# K172329: Patient Status Engine

- Pathway: 510(k) (Traditional)
- Applicant: Isansys Lifecare, Ltd.
- Decided: Apr 23, 2018 after 264 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 26 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch, Vitalconnect, Inc. (2015) Summary page 4.

## Most influential descendants
- K211305: ANNE One (2021), 6 descendants of its own
- K223711: ANNE One (2023), 4 descendants of its own
- K191620: Vitls Platform (2020), 2 descendants of its own
- K242842: ANNE View, Central Hub (2025), 1 descendant of its own
- K213863: Everion+ System (2023), 1 descendant of its own

## Indications for use
The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.

Source page: https://510kreport.com/device/K172329
Methodology: https://510kreport.com/methodology