Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CDA · 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) |
|---|---|---|---|---|---|
| K952817 | BIO-RAD URINARY 5-HIAA BY HPLC | Bio-Rad | 1995-08-01 | 42 | 0 |
| K903609 | SEROTONIN ENZYME IMMUNOASSAY | Immunotech Corp. | 1990-10-22 | 74 | 0 |
| K854946 | TDXR 5-HIAA (URINE) | Abbott Laboratories | 1986-01-17 | 38 | 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