# K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

- Pathway: 510(k) (Traditional)
- Applicant: Anumana, Inc.
- Decided: Mar 28, 2026 after 242 days
- Product code: SAT (Pulmonary Hypertension Machine Learning-Based Notification Software)
- Device class: 2
- Regulation: 21 CFR 870.2380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN230003 (2023). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250652: ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010), Anumana, Inc. (2025) Summary page 5.

## Most influential descendants
- K254297: Tempus ECG-MR (2026), 0 descendants of its own

## Indications for use
The ECG-AI PH 12-Lead algorithm is software intended to aid in earlier detection of elevated mean pulmonary arterial pressure (mPAP), an indicator of pulmonary hypertension, in adults presenting with dyspnea. ECG-AI PH 12-Lead algorithm is not intended to be a stand-alone diagnostic device for pulmonary hypertension or replace current clinical practice guidelines. A positive result may suggest the need for further clinical evaluation. Additionally, if the patient is at high risk for pulmonary hypertension, a negative result should not rule out additional clinical evaluation. ECG-AI PH 12-Lead algorithm should be applied jointly with clinician judgment. ECG-AI PH 12-Lead algorithm should not be used on ECGs from adults with an implanted pacemaker or on ECGs with a paced rhythm.

Source page: https://510kreport.com/device/K252360
Methodology: https://510kreport.com/methodology