Torax Medical, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Torax Medical, Inc.” (first 2020, latest 2023), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 80 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Torax Medical, Inc. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 54 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJN | Laparoscopic Accessories, Esophageal Sizing | 2 | 2 |
| LEI | Implant, Anti-Gastroesophageal Reflux | 1 | 0 |
Review panels
Most recent Torax Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230089 | ETHICON LINX® Esophagus Sizing Tool | QJN | 2023-02-09 | 28 |
| K201035 | ETHICON Linx Esophagus Sizing Tool | QJN | 2020-07-09 | 80 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100049 | PMA | LINX REFLUX MANAGEMENT SYSTEM | 2012-03-22 |
Recalls
5 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-04-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Torax Medical, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Torax Medical, Inc.” (first 2020, latest 2023), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Torax Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Torax Medical, Inc. is 54 days.
Which FDA product codes appear under Torax Medical, Inc.?
The most frequent FDA product codes under this applicant name are QJN (Laparoscopic Accessories, Esophageal Sizing, 2); LEI (Implant, Anti-Gastroesophageal Reflux, 1).
Next steps
- See all 2 Torax Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QJN, Torax Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.