Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MEC · 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) |
|---|---|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Olympic Medical Corp. | 2008-06-20 | 64 | 1 |
| K911120 | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 | Hamo USA, Inc. | 1994-02-03 | 1060 | 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