HeartFlow, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “HeartFlow, Inc.” (first 2016, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 128 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 85 |
| 2017 | 0 | — |
| 2018 | 1 | 129 |
| 2019 | 1 | 128 |
| 2020 | 0 | — |
| 2021 | 1 | 57 |
| 2022 | 1 | 308 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 114 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name HeartFlow, Inc. took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PJA | Coronary Vascular Physiologic Simulation Software | 8 | 7 |
Review panels
- Cardiovascular (8)
Most recent HeartFlow, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250902 | HeartFlow Analysis | PJA | 2025-07-18 | 114 |
| K213857 | HeartFlow Analysis | PJA | 2022-10-14 | 308 |
| K203329 | HeartFlow Analysis | PJA | 2021-01-08 | 57 |
| K190925 | HeartFlow FFRct Analysis | PJA | 2019-08-15 | 128 |
| K182035 | FFRct | PJA | 2018-12-06 | 129 |
| K161772 | FFRct | PJA | 2016-08-24 | 57 |
| K152733 | FFRct | PJA | 2016-01-13 | 113 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130045 | De Novo | Coronary Vascular Physiologic Simulation Software | 2014-11-26 |
Recalls
openFDA lists no recalls under a recalling firm named HeartFlow, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named HeartFlow, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01233518: Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (Completed, started 2010-10)
SEC filings
Heartflow, Inc. (HTFL): EDGAR filings, CIK 1464521. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under HeartFlow, Inc.?
FDA lists 7 510(k) clearances under the applicant name “HeartFlow, Inc.” (first 2016, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by HeartFlow, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name HeartFlow, Inc. is 114 days. Since 2017: 128 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under HeartFlow, Inc.?
The most frequent FDA product codes under this applicant name are PJA (Coronary Vascular Physiologic Simulation Software, 8).
Next steps
- See all 7 HeartFlow, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PJA, HeartFlow, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.