Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
15 daysmedian FDA review time
62 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863297 | MODIFICATION'S TO TORAY'S B-2 SERIES | National Medical Care, Medical Products Div., Inc. | 1986-09-25 | 31 | 0 |
| K772148 | CATHETER, FEMORAL VEIN, SF 6 | Sorensen Research | 1977-11-29 | 15 | 0 |
| K772146 | CATHETER, VEIN, FEMORAL, SF 10 | Sorensen Research | 1977-11-29 | 15 | 0 |
| K770047 | DNC 151 VINCA-FLO | Sorensen Research | 1977-01-14 | 4 | 0 |
| K760781 | TRIEX-1 HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1976-12-06 | 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