Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arterys, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
447 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252539 | Tempus Pixel | Arterys, Inc. | 2025-09-03 | 22 | 0 |
| K203744 | Arterys MICA | Arterys, Inc. | 2022-03-14 | 447 | 0 |
| K192437 | Arterys MICA | Arterys, Inc. | 2020-03-25 | 201 | 0 |
| K182034 | Arterys MICA | Arterys, Inc. | 2018-10-17 | 79 | 0 |
| K173542 | Arterys Oncology DL | Arterys, Inc. | 2018-01-25 | 70 | 0 |
| K171544 | Arterys Viewer | Arterys, Inc. | 2017-07-18 | 53 | 0 |
| K163253 | Arterys Cardio DL | Arterys, Inc. | 2017-01-05 | 48 | 0 |
| K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016-10-28 | 50 | 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