Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JWI · 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) |
|---|---|---|---|---|---|
| K931265 | FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND | Ferguson Medical | 1995-05-22 | 805 | 0 |
| K940297 | UNIVERSAL WRIST | Turnkey Intergration USA, Inc. | 1995-02-06 | 381 | 0 |
| K792687 | ASPERGILLUS SP., ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 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