Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LKI — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
150 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Stellar Bio Systems, Inc. | 1992-02-19 | 106 | 0 |
| K905531 | LUPUS(LE)-LATEX TEST | Immco Diagnostics, Inc. | 1991-01-25 | 46 | 0 |
| K894625 | CHLAMYDIA (LGV-1) | Bion Ent., Ltd. | 1989-08-15 | 26 | 0 |
| K883776 | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | Btc Corp. | 1989-02-03 | 150 | 0 |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | Serono Diagnostics, Inc. | 1986-01-28 | 71 | 0 |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | Immulok, Inc. | 1983-05-04 | 92 | 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