Tyrx, Inc.: FDA clearances and approvals
Tyrx, Inc. has 5 FDA 510(k) clearances (first 2010, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time: 89 days. openFDA lists 3 product recalls by a recalling firm named Tyrx, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 89 |
| 2014 | 0 | — |
| 2015 | 1 | 60 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 5 | 5 |
Review panels
Most recent Tyrx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152678 | TYRX Neuro Antibacterial Envelope | FTL | 2015-11-17 | 60 |
| K132699 | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) | FTL | 2013-11-26 | 89 |
| K131007 | AIGIS RX N MEDIUM; AIGIS RX N LARGE | FTL | 2013-07-10 | 90 |
| K130943 | AIGIS RX R PM/ AIGIS RX R ICD | FTL | 2013-05-20 | 46 |
| K093524 | PIVIT A/B ST AND PIVIT A/B ST-R | FTL | 2010-03-26 | 130 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-06-29.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Tyrx, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01043705: TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD (Completed, started 2010-01)
Frequently asked questions
How many FDA 510(k) clearances does Tyrx, Inc. have?
Tyrx, Inc. has 5 FDA 510(k) clearances (first 2010, latest 2015), across 1 product code in 1 review panel.
How long does FDA take to clear Tyrx, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tyrx, Inc.'s cleared 510(k)s is 89 days.
What devices does Tyrx, Inc. make?
Its most frequent FDA product codes are FTL (Mesh, Surgical, Polymeric, 5).
Has Tyrx, Inc. had device recalls?
openFDA lists 3 product recalls in 1 recall event by a recalling firm whose name matches Tyrx, Inc; the most recent began 2016-06-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Tyrx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Tyrx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.