Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evermed, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
133 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840846 | STERILE HICHMAN/BROVIAC INJECTION CAP | Evermed, Inc. | 1984-07-06 | 133 | 0 |
| K840529 | STEIGER TUNNELING INSTRUMENT 285 | Evermed, Inc. | 1984-03-12 | 33 | 0 |
| K830256 | NON-STERILE BROVIAC PARENTERAL ALIMI- | Evermed, Inc. | 1983-03-01 | 35 | 1 |
| K830406 | NON-STERILE CATHETER REPAIR KITS | Evermed, Inc. | 1983-03-01 | 22 | 1 |
| K830233 | NON-STERILE,SINGLE/SOUBLE LUMEN-CATH | Evermed, Inc. | 1983-02-28 | 34 | 3 |
| K830257 | NON-STERILE PERITONEAL ACCESS CATHET- | Evermed, Inc. | 1983-02-24 | 30 | 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