Cleared Traditional

K253801 - ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) (FDA 510(k) Clearance)

K253801 · Anumana, Inc. · Cardiovascular device
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Apr 2026
Decision
130d
Days
-
Risk

K253801 is an FDA 510(k) clearance for the ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040).

Submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 7, 2026 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K253801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date April 07, 2026
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code SHP
Device Class -