Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JQG · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
38 daysmedian FDA review time
72 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K811954 | COMBO-FER IRON DIAGNOSTIC | Immuno Assay Corp. | 1981-07-27 | 19 | 0 |
| K800710 | FERRITIRON KIT CAT. #RP-1100 | Ria Products, Inc. | 1980-05-14 | 44 | 0 |
| K800868 | FERRO-QUANT TM FE 59 TEST KIT | Mallinckrodt Critical Care | 1980-04-29 | 12 | 0 |
| K790133 | SPINSEP-FE59 | Nuclear Diagnostics, Inc. | 1979-03-02 | 38 | 0 |
| K780412 | TOTAL IRON BINDING CAPACITY | Diagnostic Corp. of America | 1978-05-26 | 72 | 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