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

FDA 510(k) K252360 · Anumana, Inc.

Substantially Equivalent

510(k) numberK252360

Submission

Device name
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Applicant
Anumana, Inc.
Cambridge, MA, US
Received
July 29, 2025
Decision date
March 28, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SAT – Pulmonary Hypertension Machine Learning-Based Notification Software
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2380
Specialty
Cardiovascular

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.

Other 510(k)s with product code SAT

510(k)DeviceApplicantDecision
K253699Tempus ECG-PHSAT · Traditional Tempus AI, Inc.08/21/2026SE
K233666CorVista System with PH Add-OnSAT · Traditional Analytics For Life, Inc.04/05/2024SE

More from Analytics For Life, Inc.

510(k)DeviceDecision
K260300WatchMate SoftwareQIH · Traditional 06/15/2026SE
K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP · Traditional 04/07/2026SE
K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional 07/28/2025SE
K233160NeuTrace EP Mapping System v.2.1DQK · Traditional 11/25/2023SE
K232699Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional 09/28/2023SE

Questions and answers

When was ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) cleared by the FDA?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (K252360) received a 510(k) decision of Substantially Equivalent on March 28, 2026, 242 days after the submission was received.

What is the product code of K252360?

The FDA product code is SAT – Pulmonary Hypertension Machine Learning-Based Notification Software, a Class II (moderate risk) device regulated under 21 CFR 870.2380.