Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FCC · 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) |
|---|---|---|---|---|---|
| K904668 | IE MAGNETIC EXTRACTOR | Olympus Corp. | 1991-03-21 | 157 | 0 |
| K843135 | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | Brimfield Scientific Instruments | 1984-09-26 | 48 | 0 |
| K800971 | M.R. ASSOC. MAGNETIC EXTRACTOR | Mr Associates, Inc. | 1980-05-08 | 15 | 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