Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KFJ — 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) |
|---|---|---|---|---|---|
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | Telectronics Pacing Systems, Inc. | 1991-12-31 | 119 | 0 |
| K852236 | MEDTRONIC MODEL 5867-1A | Medtronic Vascular | 1985-07-11 | 50 | 0 |
| K813518 | IMPLANT AID SPLICING CRIMP & SLEEVE | Intermedics, Inc. | 1982-01-12 | 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