Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Amcad Biomed Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
257 daysmedian FDA review time
275 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203555 | AmCAD-UT | Amcad Biomed Corporation | 2021-09-08 | 275 | 0 |
| K180867 | AmCAD-UO | Amcad Biomed Corporation | 2018-12-28 | 270 | 0 |
| K180006 | AmCAD-UT Detection 2.2 | Amcad Biomed Corporation | 2018-08-31 | 241 | 0 |
| K162574 | AmCAD-US | Amcad Biomed Corporation | 2017-05-30 | 257 | 0 |
| K170069 | AmCAD-UV | Amcad Biomed Corporation | 2017-04-26 | 107 | 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