Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJK — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
314 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-12-11 | 28 | 0 |
| K911771 | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-07-01 | 73 | 0 |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Microbiological Research Corp. | 1987-02-02 | 314 | 0 |
| K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | Widran Urological Group, Ltd. | 1986-05-02 | 14 | 0 |
| K832069 | TOXO IPA KIT IAN INDIRECT FLUORESCENT | Bionetic Laboratory Products | 1983-09-26 | 91 | 0 |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Immulok, Inc. | 1982-10-27 | 61 | 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