510(k) Report

FDA applicant

Teknar, Inc.

Fenton, MO18 decisions1980–19900 recalls

FDA records 18 decisions for Teknar, Inc. (Fenton, MO) from 1980 to 1990: 18 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Teknar, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Teknar, Inc.’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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