Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Concert Medical, LLC — 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) |
|---|---|---|---|---|---|
| K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016-09-01 | 260 | 0 |
| K153397 | S-Wire Guidewire System | Concert Medical, LLC | 2016-08-18 | 268 | 0 |
| K090193 | CONDUCTOR CORONARY GUIDEWIRE | Concert Medical, LLC | 2009-09-25 | 241 | 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