Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arlington Scientific, Inc. (Asi) · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, f | Arlington Scientific, Inc. (Asi) | 2020-10-21 | 142 | 0 |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-11-30 | 87 | 0 |
| K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018-06-14 | 227 | 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