Class Class II
HeartFlow Analysis (K250902)
Description
HeartFlow Analysis by HeartFlow, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250902
Clearance Date2025-07-18
Clearance TypeTraditional
Product CodePJA
Regulation Number870.1415
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250902
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HeartFlow Analysis (K250902) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022 |
| K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021 |
| K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019 |
| K182035 | FFRct | HeartFlow, Inc. | 2018 |
| K161772 | FFRct | HeartFlow, Inc. | 2016 |
| K122429 | VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL | Object Research Systems (Ors), Inc. | 2012 |
Trace the full predicate network for K250902
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.