Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DTJ — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
90 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962154 | CARBOMEDICS HANDLE | Carbomedics, Inc. | 1996-08-27 | 84 | 0 |
| K960169 | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | 1996-04-15 | 90 | 1 |
| K944214 | BAXTER HANDLE MODEL 1150 | Baxter Edwards | 1995-02-10 | 165 | 0 |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | 1994-07-06 | 26 | 0 |
| K880052 | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Baxter Healthcare Corp | 1988-04-01 | 86 | 0 |
| K871596 | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Shiley, Inc. | 1987-06-15 | 52 | 0 |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | American Edwards Laboratories | 1986-11-20 | 28 | 0 |
| K813276 | IONESCU-SHILEY VALVE HOLDER & HANDLE | Shiley, Inc. | 1981-12-10 | 17 | 0 |
| K811235 | DISPOSABLE HOLDER FOR HANCOCK MITRAL | Vascor, Inc. | 1981-05-13 | 9 | 0 |
| K811236 | DISPOSABLE HOLDER FOR HANCOCK AORTIC | Vascor, Inc. | 1981-05-13 | 9 | 0 |
| K792034 | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Edwards Laboratories | 1979-12-07 | 58 | 0 |
| K790022 | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Edwards Laboratories | 1979-01-15 | 12 | 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