510(k) Report

FDA applicant

Meditherm, Inc.

Parkland, FL1 decision2001–20010 recalls

FDA records 1 decision for Meditherm, Inc. (Parkland, FL) in 2001: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Meditherm, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Meditherm, 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

Which product codes does it file in?

  • LHQSystem, Telethermographic (Adjunctive Use)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003332Meditherm MED2000Meditherm, Inc. · 20011cites it

What has FDA decided for it lately?

  • K003332Meditherm MED2000Meditherm, Inc. · 2001

The one decision as Meditherm, Inc. →