Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Eder Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941206 | DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION | New Eder Corp. | 1995-07-25 | 498 | 0 |
| K941435 | BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD | New Eder Corp. | 1995-04-11 | 383 | 0 |
| K941207 | MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES | New Eder Corp. | 1995-01-24 | 316 | 0 |
| K941208 | DIAGNOSTIC SLEEVE, REDUCER SLEEVE | New Eder Corp. | 1994-06-17 | 95 | 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