Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Volcano Therapeutics, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042996 | COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AN | Volcano Therapeutics, Inc. | 2004-11-24 | 23 | 0 |
| K042188 | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM | Volcano Therapeutics, Inc. | 2004-11-10 | 90 | 0 |
| K041134 | COMBOMAP PRESSURE AND FLOW SYSTEM | Volcano Therapeutics, Inc. | 2004-06-02 | 33 | 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