Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JQE — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
194 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970248 | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYST | Canyon Diagnostics, Inc. | 1997-02-11 | 20 | 0 |
| K934358 | KODAK EKTACHEM DT SLIDES (FE) | Eastman Kodak Company | 1994-03-21 | 194 | 0 |
| K910672 | J&S PEDIATRIC IRON SATURATING REAGENT | J.S. Medical Assoc. | 1991-04-29 | 73 | 0 |
| K884649 | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | 1988-12-14 | 37 | 0 |
| K864548 | ALFERR TIBC TUBE | Benchmark Reagents | 1987-02-02 | 75 | 0 |
| K842019 | TIBC PRETREATMENT KIT | E.I. Dupont DE Nemours & Co., Inc. | 1984-06-22 | 35 | 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