Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OEG · 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) |
|---|---|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | Euroimmun Us, Inc. | 2020-09-17 | 310 | 0 |
| K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | Euroimmun Us, Inc. | 2009-03-16 | 98 | 0 |
| K071961 | MESACUP MODELS BP180 AND BP230 ELISA KITS | Mbl International Corporation | 2008-08-25 | 406 | 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