Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evans Medical, Inc. · 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) |
|---|---|---|---|---|---|
| K020530 | EVANS SUB-Q, MODEL MC4206 | Evans Medical, Inc. | 2002-04-29 | 69 | 0 |
| K935642 | EVANS MEDICAL EXTENSION SETS | Evans Medical, Inc. | 1994-01-28 | 67 | 1 |
| K935641 | 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS | Evans Medical, Inc. | 1994-01-28 | 67 | 0 |
| K935480 | MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS | Evans Medical, Inc. | 1994-01-28 | 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