Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amerimed US Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
115 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K891722 | LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO) | Amerimed US Corp. | 1989-07-14 | 115 | 0 |
| K891436 | PATIENT EXAMINATION GLOVES (LATEX) | Amerimed US Corp. | 1989-05-31 | 77 | 0 |
| K891437 | PATIENT EXAMINATION GLOVES (LATEX) | Amerimed US Corp. | 1989-05-31 | 77 | 0 |
| K890967 | VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) | Amerimed US Corp. | 1989-05-04 | 66 | 0 |
| K883522 | AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT | Amerimed US Corp. | 1988-09-30 | 44 | 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