Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arent Fox — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945843 | SAFETY PLUS | Arent Fox | 1995-07-11 | 223 | 0 |
| K944053 | NATURAL RUBBER LATEX SURGEONS GLOVE | Arent Fox | 1995-04-25 | 249 | 0 |
| K945583 | OCUSYSTEM(ART) | Arent Fox | 1995-02-13 | 91 | 0 |
| K944054 | POWDER FREE SURGEON'S GLOVE | Arent Fox | 1994-11-17 | 90 | 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