FDA applicant
Torax Medical, Inc.
FDA records 3 decisions for Torax Medical, Inc. (Shoreview, MN) from 2012 to 2023: 2 510(k) clearances and 1 original PMA approval. Most are in product codes QJN (Laparoscopic Accessories, Esophageal Sizing) and LEI (Implant, Anti-Gastroesophageal Reflux). Its devices cite 2 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Torax Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Torax Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
5in 2018
Class I Class II/III not classified
Planning a device like Torax Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report