510(k) Report

FDA applicant

Thermopeutix, Inc.

San Diego, CA5 decisions2008–20130 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Thermopeutix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2008: 12010: 12011: 12013: 2
2008high 2 (2013) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Thermopeutix, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Thermopeutix”

FDA records each applicant name separately; these may or may not be the same firm.