510(k) · Cleared
ClearedECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anumana, Inc. · SAT Pulmonary Hypertension Machine Learning-Based Notification Software
Cleared on Mar 28, 2026 as substantially equivalent to K250652 (Anumana, Inc., 2025) after a 242-day review. Its family tree reaches back 3 generations to 2023. 1 later device descends from it.
- Decided
- Mar 28, 2026
- Review
- 242 days
- Class
- Class II
- Product code
- SAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN230003 (2023). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN230003 Viz HCMViz. Ai, Inc. · 2023
- 2 generations backK232699 Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. · 2023
- 1 generation backK250652 ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. · 2025
- This deviceK252360 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)Anumana, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK254297 Tempus ECG-MRTempus AI, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254297Tempus ECG-MRTempus AI, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023 | — |
| −2 | K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023 | — |
| −1 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025 | — |
| 0 (this device) | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026 | — |
| +1 | K254297 | Tempus ECG-MR | Tempus AI, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAT device
- #1 K233666 CorVista System with PH Add-Onscore 13.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Summary page 5…ECG-AI Low Ejection Fraction 12-Lead algorithm Manufacturer: Anumana, Inc. Application Number: K250652 Device Description ECG-AI PH 12-Lead algorithm interprets 12-lead ECG voltage time series data using an artificial intelligence… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254297 | Tempus ECG-MR | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K254297 (Tempus AI, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K250652.
How does its category compare?
All SAT devicesSAT Pulmonary Hypertension Machine Learning-Based Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SAT
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SAT
Too few SAT 510(k)s in any year since 2007 to give a median.
Recalls per year · SAT
No recall names SAT since 2007.
Adverse event reports per year · SAT
No MAUDE report names SAT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252360 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252360: ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252360
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026