Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Factor, Ii, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984297 | MAGNA ABUTMENT | Factor, Ii, Inc. | 2000-01-28 | 423 | 0 |
| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | Factor, Ii, Inc. | 1988-06-01 | 127 | 0 |
| K831095 | ROYALE II | Factor, Ii, Inc. | 1983-08-31 | 149 | 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