# K192757: VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20

- Pathway: 510(k) (Traditional)
- Applicant: Vitalconnect, Inc.
- Decided: Feb 6, 2020 after 129 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: 12 generations back to K962603 (1997). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190916: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20, Vitalconnect, Inc. (2019) Summary page 4.

## Most influential descendants
- K231276: SmartCardia 7L Platform (2023), 0 descendants of its own

## Indications for use
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform 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 VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. VitalPatch device can be used on patients with pacemakers that comply with ISO 14117:2012 and ANSI/AAMI PC69:2000 without deviations. Heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are not intended for patients with pacemakers. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K192757
Methodology: https://510kreport.com/methodology