Vivio® LVEDP System

FDA 510(k) K223905 · Avicena, LLC

Substantially Equivalent

510(k) numberK223905

Submission

Device name
Vivio® LVEDP System
Applicant
Avicena, LLC
Pasadena, CA, US
Received
December 28, 2022
Decision date
October 6, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QUO – Adjunctive Heart Failure Status Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2200
Specialty
Cardiovascular

The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

Other 510(k)s with product code QUO

510(k)DeviceApplicantDecision
K251293CardioVisionQUO · Traditional Icardio.Ai11/21/2025SE
K240013EchoGo Heart Failure (2.0)QUO · Traditional Ultromics Limited09/23/2024SE
K222463EchoGo Heart FailureQUO · Traditional Ultromics Limited11/23/2022SE

More from Ultromics Limited

510(k)DeviceDecision
K183710Vivio SystemDQD · Traditional 10/04/2019SE

Questions and answers

When was Vivio® LVEDP System cleared by the FDA?

Vivio® LVEDP System (K223905) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 282 days after the submission was received.

What is the product code of K223905?

The FDA product code is QUO – Adjunctive Heart Failure Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.