# K240013: EchoGo Heart Failure (2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Ultromics Limited
- Decided: Sep 23, 2024 after 265 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 5.

## Indications for use
EchoGo Heart Failure 2.0 is an automated machine learning-based decision support system, indicated as a diagnostic aid for patients undergoing routine functional cardiovascular assessment using echocardiography. When utilised by an interpreting clinician, this device provides information that may be useful in detecting heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure 2.0 is indicated in adult populations over 25 years of age. Patient management decisions should not be made solely on the results of the EchoGo Heart Failure 2.0 analysis. EchoGo Heart Failure 2.0 takes as input an apical 4-chamber view of the heart that has been captured and assessed to have an ejection fraction 50%.

Source page: https://510kreport.com/device/K240013
Methodology: https://510kreport.com/methodology