Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coagusense, 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) |
|---|---|---|---|---|---|
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Pati | Coagusense, Inc. | 2022-10-05 | 399 | 0 |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019-02-21 | 92 | 1 |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | Coagusense, Inc. | 2010-04-07 | 174 | 1 |
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