Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excel U.S.A. — 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) |
|---|---|---|---|---|---|
| K896908 | EXCEL STIM II | Excel U.S.A. | 1990-02-20 | 71 | 0 |
| K892128 | PATIENT EXAMINATION GLOVES (LATEX) | Excel U.S.A. | 1989-05-11 | 36 | 0 |
| K881791 | STERA DISPOSABLE SYRINGES | Excel U.S.A. | 1988-12-22 | 240 | 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