510(k) · Cleared
ClearedHeartFlow Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HeartFlow, Inc. · PJA Coronary Vascular Physiologic Simulation Software
Cleared on Jan 8, 2021 as substantially equivalent to K190925 (HeartFlow, Inc., 2019) after a 57-day review. Its family tree reaches back 5 generations to 2014. 2 later devices descend from it.
- Decided
- Jan 8, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- PJA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN130045 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backDEN130045 Heartflow FfrctHeartflow · 2014
- 4 generations backK152733 FFRctHeartFlow, Inc. · 2016
- 3 generations backK161772 FFRctHeartFlow, Inc. · 2016
- 2 generations backK182035 FFRctHeartFlow, Inc. · 2018
- 1 generation backK190925 HeartFlow FFRct AnalysisHeartFlow, Inc. · 2019
- This deviceK203329 HeartFlow AnalysisHeartFlow, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213857 HeartFlow AnalysisHeartFlow, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK250902 HeartFlow AnalysisHeartFlow, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN130045 | Heartflow Ffrct | Heartflow | 2014 | — |
| −4 | K152733 | FFRct | HeartFlow, Inc. | 2016 | — |
| −3 | K161772 | FFRct | HeartFlow, Inc. | 2016 | — |
| −2 | K182035 | FFRct | HeartFlow, Inc. | 2018 | — |
| −1 | K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019 | — |
| 0 (this device) | K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021 | — |
| +1 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022 | — |
| +2 | K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 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
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 |
|---|---|---|---|
| * | K190925 | HeartFlow FFRct AnalysisSummary page 4…Code: PJA Product Class: Class II (21 CFR 870.1415) 3 Predicates HeartFlow FFRCT v2.Planner (K190925) is the identified predicate for this submission. HeartFlow, Inc.… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213857 | HeartFlow Analysis | 2022 | 1 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K213857 (HeartFlow, Inc., 2022) has gone furthest, with 1 descendant 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. 2021, 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?
The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides the calculations of FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static…
Read the full statement (126 words)
The HeartFlow Analysis is a coronary physiologic simulation software for the clinical quantitative and qualitative
analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with
coronary artery disease. It provides the calculations of 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. The HeartFlow Analysis is intended to support the functional evaluation of coronary artery disease.
The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and assessment of coronary
arteries. The HeartFlow Analysis is 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203329: HeartFlow Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203329
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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