De Novo · Granted
GrantedHeartflow Ffrct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartflow · PJA Coronary Vascular Physiologic Simulation Software
Granted on Nov 26, 2014 as a new device type through De Novo after a 387-day review. 11 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 387 days
- Class
- Class II
- Product code
- PJA
- Recalls
- None
11 later devices descend from it, 2 citing it directly.
- This deviceDEN130045 Heartflow FfrctHeartflow · 2014
- Descendant · cites it directly · 9 of its ownK152733 FFRctHeartFlow, Inc. · 2016
- Descendant · 2 generations on · 8 of its ownK161772 FFRctHeartFlow, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK182035 FFRctHeartFlow, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK190925 HeartFlow FFRct AnalysisHeartFlow, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK203329 HeartFlow AnalysisHeartFlow, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K152733FFRctHeartFlow, Inc. · 2016 · cites it directly9descendants
- K161772FFRctHeartFlow, Inc. · 2016 · 2 generations on8descendants
- K182035FFRctHeartFlow, Inc. · 2018 · 3 generations on4descendants
- K190925HeartFlow FFRct AnalysisHeartFlow, Inc. · 2019 · 4 generations on3descendants
- K203329HeartFlow AnalysisHeartFlow, Inc. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130045 | Heartflow Ffrct | Heartflow | 2014 | — |
| +1 | K152733 | FFRct | HeartFlow, Inc. | 2016 | — |
| +2 | K161772 | FFRct | HeartFlow, Inc. | 2016 | — |
| +3 | K182035 | FFRct | HeartFlow, Inc. | 2018 | — |
| +4 | K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019 | — |
| +5 | K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 PJA? 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 PJA device
- #1 K250902 HeartFlow Analysisscore 13.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K152733 (HeartFlow, Inc., 2016) has gone furthest, with 9 descendants of its own.
How does its category compare?
All PJA devicesPJA Coronary Vascular Physiologic Simulation Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PJA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PJA
Too few PJA 510(k)s in any year since 2007 to give a median.
Recalls per year · PJA
No recall names PJA since 2007.
Adverse event reports per year · PJA
16in 2025
MAUDE reports naming product code PJA, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 1 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
HeartFlow FFRCT is a post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is…
Read the full statement (130 words)
HeartFlow FFRCT is a post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. It is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130045 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130045: Heartflow Ffrct.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130045
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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