Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MQA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202540 | EliA Rib-P | Phadia AB | 2021-09-13 | 376 | 0 |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | Theratest Laboratories, Inc. | 2003-02-06 | 62 | 0 |
| K981237 | QUANTA LITE RIBOSOME P ELISA | Inova Diagnostics, Inc. | 1998-06-05 | 63 | 0 |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | Hogan & Hartson | 1996-05-23 | 492 | 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