Amerasia Corp.: FDA clearances and approvals
Amerasia Corp. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time: 120 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYF | Cap, Surgical | 3 | 3 |
| FXP | Cover, Shoe, Operating-Room | 2 | 2 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
Review panels
Most recent Amerasia Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955833 | NIOMED SURGICAL CAPS | FYF | 1996-03-15 | 80 |
| K954747 | NIOMED BARRIER GOWNS | FYC | 1996-03-06 | 142 |
| K954455 | NIOMED BOUFFANT CAPS | FYF | 1996-01-23 | 120 |
| K954454 | NIOMED SURGICAL HOOD | FYF | 1996-01-23 | 120 |
| K952937 | NIOMED NON-SKID SHOE COVERS | FXP | 1995-10-23 | 119 |
| K952897 | NIOMED SHOE COVERS | FXP | 1995-10-23 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Amerasia Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Amerasia Corp. have?
Amerasia Corp. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 3 product codes in 2 review panels.
How long does FDA take to clear Amerasia Corp.'s 510(k)s?
The median time from FDA receipt to decision across Amerasia Corp.'s cleared 510(k)s is 120 days.
What devices does Amerasia Corp. make?
Its most frequent FDA product codes are FYF (Cap, Surgical, 3); FXP (Cover, Shoe, Operating-Room, 2); FYC (Gown, Isolation, Surgical, 1).
Has Amerasia Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Amerasia Corp. Related entities may recall under other names.
Next steps
- See all 6 Amerasia Corp. clearances with predicates and recalls
- Run predicate analysis for product code FYF, Amerasia Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.