Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FJQ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893679 | SHUNT CONNECTORS | Akcess Medical Products, Inc. | 1989-07-24 | 69 | 0 |
| K771422 | PATIENT BY-PASS | Quinton, Inc. | 1978-01-03 | 155 | 0 |
| K771429 | DISP. TEFLON CONNHCTOR | Quinton, Inc. | 1977-12-22 | 143 | 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