Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Volcano Atheromed, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
157 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X | Volcano Atheromed, Inc. | 2021-06-14 | 28 | 0 |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | 2020-04-20 | 152 | 0 |
| K182972 | Phoenix Atherectomy System | Volcano Atheromed, Inc. | 2018-12-20 | 55 | 0 |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | Volcano Atheromed, Inc. | 2018-12-17 | 157 | 0 |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoe | Volcano Atheromed, Inc. | 2017-08-24 | 16 | 0 |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | Volcano Atheromed, Inc. | 2015-05-26 | 27 | 0 |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm | Volcano Atheromed, Inc. | 2014-12-19 | 29 | 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