Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OPX · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambd | The Binding Site Group , Ltd. | 2016-06-16 | 84 | 0 |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Hu | The Binding Site Group , Ltd. | 2015-11-06 | 130 | 0 |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLI | The Binding Site | 2014-03-18 | 62 | 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