Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HJN — 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) |
|---|---|---|---|---|---|
| K941035 | VENOSCOPE | Trinity Partners, LLC | 1994-05-16 | 70 | 0 |
| K912747 | LULMITEX NEONATAL TRANSILLUMINATOR | Lumitex, Inc. | 1991-12-24 | 186 | 0 |
| K901309 | SYLVAN PEDIASCAN 200 TRANSILLUMINATOR | Sylvan Corp. | 1990-05-24 | 65 | 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