Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LEB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
37 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842986 | REFRAX MOUNTING MEDIUM | Anatech, Ltd. | 1984-08-21 | 22 | 0 |
| K821019 | PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU | Microbiological Research Corp. | 1982-04-26 | 14 | 0 |
| K812193 | KOH MOUNTING FLUID | American Scientific Products | 1981-08-31 | 28 | 0 |
| K811799 | CLEAR-MOUNT | Richard-Allan Medical Ind., Inc. | 1981-07-31 | 37 | 0 |
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | I M, Inc. | 1976-11-16 | 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