Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FEH · 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) |
|---|---|---|---|---|---|
| K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Optim, LLC | 2013-04-19 | 53 | 0 |
| K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- | Optim, LLC | 2012-09-13 | 20 | 0 |
| K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE | American Cystocope Makers, Inc. | 1981-01-15 | 28 | 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