510(k) · Cleared
ClearedECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anumana, Inc. · SHP Cardiac Amyloidosis Machine Learning-Based Notification Software
Cleared on Apr 7, 2026 as substantially equivalent to K250652 (Anumana, Inc., 2025) after a 130-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- Apr 7, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- SHP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN230003 (2023). No later device cites it as a predicate yet.
- Root · 3 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 2 generations backK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- 1 generation backK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- This deviceK253801 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −2 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| −1 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025 | — |
| 0 (this device) | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Summary page 5…ECG-AI Low Ejection Fraction 12-Lead algorithm Manufacturer: Anumana, Inc. Application Number: K250652 Device Description The ECG-AI CA 12-Lead algorithm is software as a medical device (SaMD) which interprets 12-lead ECG voltage t… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K250652.
How does its category compare?
All SHP devicesSHP Cardiac Amyloidosis Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHP
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHP
Too few SHP 510(k)s in any year since 2007 to give a median.
Recalls per year · SHP
No recall names SHP since 2007.
Adverse event reports per year · SHP
No MAUDE report names SHP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (141 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253801: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253801
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026