EchoGo Heart Failure

FDA 510(k) K222463 · Ultromics Limited

Substantially Equivalent

510(k) numberK222463

Submission

Device name
EchoGo Heart Failure
Applicant
Ultromics Limited
Oxford, GB
Received
August 15, 2022
Decision date
November 23, 2022
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
K223905Vivio® LVEDP SystemQUO · Traditional Avicena, LLC10/06/2023SE

More from Avicena, LLC

510(k)DeviceDecision
K240860EchoGo Amyloidosis (1.0)SDJ · Traditional 11/15/2024SE
K240013EchoGo Heart Failure (2.0)QUO · Traditional 09/23/2024SE
K213275EchoGo Core (2.0)QIH · Traditional 12/20/2021SE
K201555EchoGo ProPOK · Traditional 12/18/2020SE
K191171EchoGo CoreQIH · Traditional 11/13/2019SE

Questions and answers

When was EchoGo Heart Failure cleared by the FDA?

EchoGo Heart Failure (K222463) received a 510(k) decision of Substantially Equivalent on November 23, 2022, 100 days after the submission was received.

What is the product code of K222463?

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