Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barrx Medical, 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) |
|---|---|---|---|---|---|
| K120431 | HALO90 ULTRA ABLATION CATHETER | Barrx Medical, Inc. | 2012-05-03 | 80 | 0 |
| K112454 | HALO60 ABLATION CATHETER | Barrx Medical, Inc. | 2012-01-05 | 133 | 0 |
| K101111 | HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION | Barrx Medical, Inc. | 2010-06-18 | 58 | 1 |
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