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FDA 510(k)

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

K-Number: K252360 · 2026-03-28

ApplicantAnumana, Inc.
Decision Date2026-03-28
Product CodeSAT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2026-03-28 under 510(k) number K252360. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is a medical device that received FDA 510(k) clearance on 2026-03-28. The listed applicant is Anumana, Inc.. The 510(k) number is K252360.

When did ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) receive FDA 510(k) clearance?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) received FDA 510(k) clearance on 2026-03-28, under 510(k) number K252360.

Who is the listed applicant for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

The FDA 510(k) record lists Anumana, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

The FDA product code for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is SAT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05873387Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic StethoscopeRECRUITINGNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT05237505The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)RECRUITINGNCT06564896Comparative Assessment of Sleep Positive Airway Pressure Modalities (CASPAM)RECRUITINGNCT06589700B2AD-Risk AFDAS Evolution of Burden of AFRECRUITINGNCT06911632Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary HypertensionRECRUITING

Other records listing Anumana, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260300WatchMate SoftwareK253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)K233160NeuTrace EP Mapping System v.2.1K232699Low Ejection Fraction AI-ECG Algorithm

Related Devices (Code: SAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233666CorVista System with PH Add-OnAnalytics For Life, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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