# K211365: Alio Medical Remote Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Graftworx, Inc. Dba Alio
- Decided: Mar 24, 2022 after 324 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.
3 later devices descend from it; 3 cite it directly.
0 of 30 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
- K252984: Perin Health System (PHD80060-2) (2026), 0 descendants of its own
- K252440: EasyTeleMed (2.0.2) (2025), 0 descendants of its own
- K223073: Alio (2023), 0 descendants of its own

## Indications for use
The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review. The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated. The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.

Source page: https://510kreport.com/device/K211365
Methodology: https://510kreport.com/methodology