Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barrx Medical, Incorporated — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
89 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | Barrx Medical, Incorporated | 2010-01-15 | 30 | 0 |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | Barrx Medical, Incorporated | 2010-01-08 | 102 | 0 |
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | Barrx Medical, Incorporated | 2009-11-10 | 89 | 1 |
| K083737 | HALO ABLATION CATHETER | Barrx Medical, Incorporated | 2009-02-10 | 56 | 0 |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, | Barrx Medical, Incorporated | 2009-02-02 | 49 | 0 |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | Barrx Medical, Incorporated | 2008-10-08 | 64 | 0 |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | Barrx Medical, Incorporated | 2008-04-02 | 34 | 0 |
| K071543 | HALO360' COAGULATION CATHETER | Barrx Medical, Incorporated | 2007-06-29 | 24 | 0 |
| K062441 | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUT | Barrx Medical, Incorporated | 2006-11-14 | 85 | 0 |
| K062723 | HALO90 COAGULATION CATHETER | Barrx Medical, Incorporated | 2006-11-09 | 58 | 0 |
| K062225 | HALO COAGULATION CATHETER | Barrx Medical, Incorporated | 2006-08-28 | 26 | 0 |
| K060169 | BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERA | Barrx Medical, Incorporated | 2006-04-21 | 88 | 0 |
| K051168 | BARRX HALO 360 SYSTEM, MODEL 1100C-115A | Barrx Medical, Incorporated | 2005-06-29 | 55 | 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