# K183078: VitalConnect Platform, VitalPatch Biosensor

- Pathway: 510(k) (Traditional)
- Applicant: Vitalconnect, Inc.
- Decided: Mar 7, 2019 after 122 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: 10 generations back to K962603 (1997). 27 ancestors in all.
9 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)
- K163453: VitalPatch® VitalConnect Platform, Vitalconnect, Inc. (2017) Summary page 4.

## Most influential descendants
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K190916: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (2019), 2 descendants of its own
- K222010: Biobeat Platform-2 and BB-613WP Patch (2022), 1 descendant of its own
- K192757: VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 (2020), 1 descendant 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 Biosensor 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. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K183078
Methodology: https://510kreport.com/methodology