Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJF · 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) |
|---|---|---|---|---|---|
| K003104 | BACT/ALERT CSR | Organon Teknika Corp. | 2000-10-20 | 52 | 0 |
| K830372 | ARTIMICROBIAL REMOVAL DEVICE | Marion Laboratories, Inc. | 1983-04-08 | 63 | 0 |
| K830363 | BACTEC 170 TRYPTIC SOY BROTH W/RESINS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-24 | 48 | 0 |
| K822344 | ANTIMICROBIAL REMOVAL DEVICE (ARD) | Marion Laboratories, Inc. | 1982-08-25 | 20 | 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