Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stephens Scientific — 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) |
|---|---|---|---|---|---|
| K893772 | TISSUE EMBEDDING MEDIUM | Stephens Scientific | 1989-06-22 | 31 | 0 |
| K881359 | DECALCIFYING SOLUTION II | Stephens Scientific | 1988-04-19 | 19 | 0 |
| K872625 | DECALCIFYING SOLUTION | Stephens Scientific | 1987-08-06 | 31 | 0 |
| K832011 | AMERI CLEAR | Stephens Scientific | 1983-08-12 | 50 | 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