Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OZT · Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
113 daysmedian FDA review time
268 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253855 | KardiaPSI Balloon Catheter | Intervention Tech, Inc. ; dba Corvention | 2026-05-06 | 154 | 0 |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | 2026-03-20 | 37 | 0 |
| K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec | 2025-03-11 | 284 | 0 |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2024-07-31 | 113 | 0 |
| K231814 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | 2023-10-12 | 113 | 0 |
| K220881 | INOUE BALLOON A | Toray Industries, Inc. | 2022-12-18 | 268 | 0 |
| K172932 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2017-12-13 | 78 | 0 |
| K152613 | True Flow Valvuloplasty Perfusion Catheter | C.R. Bard, Inc. | 2016-01-19 | 127 | 0 |
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015-12-18 | 137 | 0 |
| K150667 | True Dilatation Balloon Valvuloplasty Catheter | C.R. Bard, Inc. | 2015-06-17 | 93 | 0 |
| K142083 | TRUE FLOW VALVULOPLASTY PERFUSION CATHETER | C.R. Bard, Inc. | 2015-04-17 | 260 | 0 |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015-04-03 | 51 | 0 |
| K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter | Edwards Lifesciences | 2014-10-29 | 79 | 0 |
| K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER | C.R. Bard, Inc. | 2014-09-18 | 58 | 0 |
| K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER | Edwards Lifesciences, LLC | 2014-07-03 | 154 | 0 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2014-02-11 | 78 | 1 |
| K133569 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 C | Bard Peripheral Vascular, Inc. | 2013-12-20 | 30 | 0 |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-11-22 | 80 | 0 |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-01-31 | 120 | 0 |
| K121083 | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATH | Loma Vista Medical | 2012-10-11 | 184 | 1 |
| K122012 | Z-MED Z-MED II | NuMED, Inc. | 2012-10-04 | 86 | 0 |
| DEN080015 | NUCLEUS-X PTV CATHETER | NuMED, Inc. | 2012-06-11 | 1265 | 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