510(k) Report

FDA applicant

Thermatrek

Woodbury, CT2 decisions1998–20030 recalls

FDA records 2 decisions for Thermatrek (Woodbury, CT) from 1998 to 2003: 2 510(k) clearances. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). No recall is linked to its devices.

FDA’s records also spell it “Thermatrek, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Thermatrek since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thermatrek by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thermatrek’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