510(k) Report

FDA applicant

Clini-Therm Corp.

Walker, MI2 decisions1984–19850 recalls

FDA records 2 decisions for Clini-Therm Corp. (Walker, MI) from 1984 to 1985: 1 510(k) clearance and 1 original PMA approval. Most are in product codes FLL (Continuous Measurement Thermometer) and LOC (System, Rf/Microwave Hyperthermia, Cancer…). 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, general hospital panel, where it files most

How often FDA has decided Clini-Therm Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clini-Therm Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Clini-Therm Corp.’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