Amcad Biomed Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Amcad Biomed Corporation” (first 2017, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 257 days. Since 2017 the median was 257 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 182 |
| 2018 | 2 | 256 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 275 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Amcad Biomed Corporation took a median 257 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (5)
Most recent Amcad Biomed Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203555 | AmCAD-UT | QIH | 2021-09-08 | 275 |
| K180867 | AmCAD-UO | LLZ | 2018-12-28 | 270 |
| K180006 | AmCAD-UT Detection 2.2 | LLZ | 2018-08-31 | 241 |
| K162574 | AmCAD-US | LLZ | 2017-05-30 | 257 |
| K170069 | AmCAD-UV | LLZ | 2017-04-26 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Amcad Biomed Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Amcad Biomed Corporation?
FDA lists 5 510(k) clearances under the applicant name “Amcad Biomed Corporation” (first 2017, latest 2021), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Amcad Biomed Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amcad Biomed Corporation is 257 days. Since 2017: 257 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Amcad Biomed Corporation?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 5 Amcad Biomed Corporation clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Amcad Biomed Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.