FDA applicant
Thermopeutix, Inc.
FDA records 5 decisions for Thermopeutix, Inc. (San Diego, CA) from 2008 to 2013: 5 510(k) clearances. Most are in product codes MJN (Catheter, Intravascular Occluding, Temporary) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Thermopeutix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Thermopeutix, 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) ReportOther applicant names beginning “Thermopeutix”
FDA records each applicant name separately; these may or may not be the same firm.