510(k) Report

FDA applicant

Lectec Corp.

Minnetonka, MN27 decisions1977–19960 recalls

FDA records 27 decisions for Lectec Corp. (Minnetonka, MN) from 1977 to 1996: 27 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and KGX (Tape And Bandage, Adhesive). 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 Lectec Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lectec Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lectec Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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