Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QHA — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
239 daysmedian FDA review time
265 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251355 | X1-FFR | Spectrawave, Inc. | 2025-10-17 | 170 | 0 |
| K243769 | QFR (3.0) | Qfr Solutions BV | 2025-04-04 | 119 | 0 |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024-04-09 | 265 | 0 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 | 27 | 0 |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023-02-28 | 260 | 0 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 | 239 | 0 |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019-05-30 | 251 | 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