Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biopool Intl., Inc. — 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) |
|---|---|---|---|---|---|
| K002642 | MINIQUANT D-DIMER, MODEL 1447 | Biopool Intl., Inc. | 2001-02-05 | 165 | 0 |
| K983898 | BIOCLOT APC SENSITIVITY | Biopool Intl., Inc. | 1999-01-06 | 64 | 0 |
| K981752 | I-STAT COAGULATION CONTROL SET | Biopool Intl., Inc. | 1998-06-15 | 28 | 0 |
| K980314 | FETAL D TECTION KIT | Biopool Intl., Inc. | 1998-04-08 | 71 | 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