Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DOY · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
40 daysmedian FDA review time
85 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910154 | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER | C.R. Bard, Inc. | 1991-04-09 | 85 | 0 |
| K832396 | CENTRAL VENOUS ACCESS CATHETER CVAC | Gish Biomedical, Inc. | 1983-08-31 | 42 | 0 |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | Medical Parameters, Inc. | 1983-05-25 | 40 | 0 |
| K831191 | VASCULAR CATHETER | Medrad, Inc. | 1983-05-09 | 27 | 0 |
| K831188 | CONNECTOR TUBE | Medrad, Inc. | 1983-05-09 | 27 | 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