# K253801: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)

- Pathway: 510(k) (Traditional)
- Applicant: Anumana, Inc.
- Decided: Apr 7, 2026 after 130 days
- Product code: SHP (Cardiac Amyloidosis Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN230003 (2023). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010), Anumana, Inc. (2025) Summary page 5.

## Indications for use
The ECG-AI Cardiac Amyloidosis 12-Lead Algorithm is software as a medical device intended to aid in earlier detection of Cardiac Amyloidosis in adults being evaluated for signs or symptoms consistent with cardiac amyloidosis. This population includes patients that have at least one condition commonly associated with cardiac amyloidosis, such as: unexplained heart failure, nephrotic syndrome, peripheral neuropathy, arrhythmias, or aortic stenosis. The ECG-AI Cardiac Amyloidosis 12-Lead Algorithm is not intended to be a stand-alone diagnostic device for cardiac amyloidosis nor to replace current clinical practice guidelines. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of Cardiac Amyloidosis. Additionally, if the patient is at high risk for the cardiac condition, a negative result should not rule out additional clinical evaluation. The ECG-AI Cardiac Amyloidosis 12-Lead algorithm should be applied jointly with clinician judgment.

Source page: https://510kreport.com/device/K253801
Methodology: https://510kreport.com/methodology