Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PCN · 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) |
|---|---|---|---|---|---|
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambd | The Binding Site Group , Ltd. | 2018-02-15 | 168 | 0 |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylit | The Binding Site Group , Ltd. | 2016-10-04 | 90 | 0 |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA K | The Binding Site | 2013-12-20 | 128 | 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