# K191870: VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

- Pathway: 510(k) (Traditional)
- Applicant: VivaLNK, Inc.
- Decided: Jan 7, 2020 after 179 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: 21 generations back to K941811 (1994). 153 ancestors in all.
No later device cites it as a predicate yet.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132447: Vitalconnect Platform by Vital Connect Inc., Vitalconnect, Inc. (2014) Summary page 4.
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library), Vitalconnect, Inc. (2014) Summary page 4.

## Indications for use
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

Source page: https://510kreport.com/device/K191870
Methodology: https://510kreport.com/methodology