# K223905: Vivio® LVEDP System

- Pathway: 510(k) (Traditional)
- Applicant: Avicena, LLC
- Decided: Oct 6, 2023 after 282 days
- Product code: QUO (Adjunctive Heart Failure Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222463: EchoGo Heart Failure, Ultromics Limited (2022) Summary page 4.

## Indications for use
The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.

Source page: https://510kreport.com/device/K223905
Methodology: https://510kreport.com/methodology