# K193343: Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

- Pathway: 510(k) (Traditional)
- Applicant: Vitalconnect, Inc.
- Decided: Apr 20, 2020 after 139 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170973: VitalWatch Software User Interface, Vitalconnect, Inc. (2017) Summary page 4.

## Recalls of this device
- May 21, 2020 · Class II · Z-2537-2020: A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software def

## Indications for use
Vista Solution 2.1 is a software user interface intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare settings. Vista Solution 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/K193343
Methodology: https://510kreport.com/methodology