Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ArteryFlow Technology Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
260 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231353 | AccuCTP Pro | ArteryFlow Technology Co., Ltd. | 2023-09-14 | 127 | 0 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 | 27 | 0 |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023-02-28 | 260 | 0 |
| K220663 | AccuCTP | ArteryFlow Technology Co., Ltd. | 2022-11-22 | 260 | 0 |
| K213838 | AneuGuide | ArteryFlow Technology Co., Ltd. | 2022-06-01 | 174 | 0 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 | 239 | 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