Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Precision Biologic, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
367 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025-08-25 | 108 | 0 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023-09-13 | 359 | 0 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | 2022-12-23 | 367 | 0 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | 2019-03-12 | 90 | 0 |
| K060284 | CRYOCHECK CLOT APCR | Precision Biologic, Inc. | 2006-05-10 | 96 | 0 |
| K043571 | CRYOCHECK CLOT S | Precision Biologic, Inc. | 2005-03-18 | 81 | 0 |
| K040987 | CRYOCHECK CLOT C | Precision Biologic, Inc. | 2004-06-18 | 64 | 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