Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IDC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853187 | ACRIDINE ORANGE FLUORESCENT STAIN | Advanced Medical Technology, Inc. | 1985-08-13 | 14 | 0 |
| K812212 | ACRIDINE ORANGE STAIN | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 | 27 | 0 |
| K803304 | ACRIDINE ORANGE STAIN | Remel Co. | 1981-02-12 | 44 | 0 |
| K810040 | ACRIDINE ORANGE STAIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-02-12 | 34 | 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