Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NBO — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESM | Euroimmun Us, Inc. | 2010-09-02 | 428 | 0 |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | Rhigene, Inc. | 2000-06-09 | 127 | 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