Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Access Bio, Inc. — 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) |
|---|---|---|---|---|---|
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025-08-22 | 87 | 0 |
| K241915 | CareSuperbâ„¢ COVID-19 Antigen Home Test | Access Bio, Inc. | 2025-01-29 | 212 | 0 |
| K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020-02-18 | 256 | 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