Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Amerasia Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
142 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955833 | NIOMED SURGICAL CAPS | Amerasia Corp. | 1996-03-15 | 80 | 0 |
| K954747 | NIOMED BARRIER GOWNS | Amerasia Corp. | 1996-03-06 | 142 | 0 |
| K954454 | NIOMED SURGICAL HOOD | Amerasia Corp. | 1996-01-23 | 120 | 0 |
| K954455 | NIOMED BOUFFANT CAPS | Amerasia Corp. | 1996-01-23 | 120 | 0 |
| K952937 | NIOMED NON-SKID SHOE COVERS | Amerasia Corp. | 1995-10-23 | 119 | 0 |
| K952897 | NIOMED SHOE COVERS | Amerasia Corp. | 1995-10-23 | 122 | 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