Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPK · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
243 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971966 | CORONARY VEIN GRAFT TAG MARKER | Med-Edge, Inc. | 1998-01-26 | 243 | 0 |
| K895369 | VOSS GRAFT MARKER | Voss Medical Products | 1989-09-27 | 29 | 0 |
| K864919 | SCANLAN (TM) VEIN/GRAFT HOLDER | Scanlan Intl., Inc. | 1987-01-12 | 27 | 0 |
| K864101 | COOK (R) VEIN GRAFT RING MARKERS | Cook, Inc. | 1986-10-30 | 9 | 0 |
| K801637 | FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. | C.R. Bard, Inc. | 1980-08-27 | 41 | 0 |
| K770802 | MARKERS, STAINLESS STEEL | Cardio-Surgical, Inc. | 1977-06-27 | 62 | 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