Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KFC · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
71 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875310 | RETICULOCYTE STAIN | Sigma Diagnostics, Inc. | 1988-02-09 | 42 | 0 |
| K843919 | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | Difco Laboratories, Inc. | 1984-10-30 | 25 | 0 |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Reagent Laboratory, Inc. | 1984-09-11 | 71 | 0 |
| K842926 | METHYLENE BLUE STAIN, LOEFFLER | E K Ind., Inc. | 1984-09-11 | 48 | 0 |
| K842743 | NEW METHYLENE BLUE N | E K Ind., Inc. | 1984-08-12 | 30 | 0 |
| K831502 | NEPHROLYTE | Flaitron Laboratories, Inc. | 1983-07-18 | 68 | 0 |
| K770792 | TUBE, STAIN, RETICULOCYTE, LARC | Corning Medical & Scientific | 1977-07-05 | 64 | 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