Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Access Bio Incorporate — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051925 | CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN | Access Bio Incorporate | 2005-11-29 | 134 | 0 |
| K032159 | CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY | Access Bio Incorporate | 2003-09-05 | 52 | 0 |
| K031048 | CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PL | Access Bio Incorporate | 2003-06-16 | 75 | 0 |
| K031052 | CARESTART HCG ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-13 | 72 | 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