Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kabivitrum, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
157 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884058 | COATEST PROTEIN C | Kabivitrum, Inc. | 1988-12-13 | 78 | 0 |
| K854572 | COATEST PLASMINOGEN | Kabivitrum, Inc. | 1986-02-26 | 104 | 0 |
| K844664 | THE I.V. BAG | Kabivitrum, Inc. | 1985-05-06 | 157 | 0 |
| K833890 | COATEST ANTIPLASMIN | Kabivitrum, Inc. | 1984-01-30 | 82 | 0 |
| K833891 | COATEST HEPARIN | Kabivitrum, Inc. | 1984-01-30 | 82 | 0 |
| K833892 | COATEST FACTOR VIII | Kabivitrum, Inc. | 1984-01-30 | 82 | 0 |
| K832114 | COATEST FACTOR X | Kabivitrum, Inc. | 1983-08-26 | 57 | 0 |
| K812829 | COATEST ANTITHROMBIN | Kabivitrum, Inc. | 1981-12-30 | 83 | 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