Cleared Traditional

K252360 - ECG-AI Pulmonary Hypertension (PH) 12-L...

K252360 is an FDA 510(k) clearance for ECG-AI Pulmonary Hypertension (PH) 12-L..., manufactured by Anumana, Inc.. The device is a Class 2 Cardiovascular device with product code SAT cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K252360 · Anumana, Inc. · Cardiovascular device
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Mar 2026
Decision
242d
Days
Class 2
Risk

K252360 is an FDA 510(k) clearance for the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020). Classified as Pulmonary Hypertension Machine Learning-based Notification Software (product code SAT), Class II - Special Controls.

Submitted by Anumana, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 28, 2026 after a review of 242 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2380 - the FDA cardiovascular device oversight framework. 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.

View all Anumana, Inc. devices

FDA 510(k) Submission Details - K252360

510(k) Number K252360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2025
Decision Date March 28, 2026
Days to Decision 242 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SAT Device Classification - Class 2, Special Controls

Product Code SAT Pulmonary Hypertension Machine Learning-based Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2380
Definition Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.