Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PJA · Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
387 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025-07-18 | 114 | 0 |
| K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022-10-14 | 308 | 0 |
| K213657 | DEEPVESSEL FFR | Keyamed Na, Inc. | 2022-04-01 | 133 | 0 |
| K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021-01-08 | 57 | 0 |
| K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019-08-15 | 128 | 0 |
| K182035 | FFRct | HeartFlow, Inc. | 2018-12-06 | 129 | 0 |
| K161772 | FFRct | HeartFlow, Inc. | 2016-08-24 | 57 | 0 |
| K152733 | FFRct | HeartFlow, Inc. | 2016-01-13 | 113 | 0 |
| DEN130045 | HEARTFLOW FFRCT | Heartflow | 2014-11-26 | 387 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda