Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GCC · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
72 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | Med Institute, Inc. | 1998-05-26 | 64 | 0 |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Med Institute, Inc. | 1992-07-30 | 72 | 0 |
| K902502 | BYRD STAINLESS STEEL DILATOR | Medical Engineering and Development Institute | 1990-08-07 | 63 | 0 |
| K893480 | BYRD EXTRACTOR SET | Medical Engineering and Development Institute | 1989-06-23 | 50 | 0 |
| K820865 | VAN-TEC FASCIAL DILATOR | Van-Tec, Inc. | 1982-05-05 | 37 | 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