Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tyrx, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152678 | TYRX Neuro Antibacterial Envelope | Tyrx, Inc. | 2015-11-17 | 60 | 0 |
| K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | Tyrx, Inc. | 2013-11-26 | 89 | 0 |
| K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE | Tyrx, Inc. | 2013-07-10 | 90 | 0 |
| K130943 | AIGIS RX R PM/ AIGIS RX R ICD | Tyrx, Inc. | 2013-05-20 | 46 | 0 |
| K093524 | PIVIT A/B ST AND PIVIT A/B ST-R | Tyrx, Inc. | 2010-03-26 | 130 | 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