Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tyrx Pharma, 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) |
|---|---|---|---|---|---|
| K063091 | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0 | Tyrx Pharma, Inc. | 2008-01-16 | 463 | 0 |
| K053656 | TYRX ANTIMICROBIAL MESH | Tyrx Pharma, Inc. | 2006-07-14 | 196 | 0 |
| K052864 | TYRX SURGICAL MESH, MODEL SMPC-0501 | Tyrx Pharma, Inc. | 2005-12-22 | 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