510(k) Report

FDA applicant

Kay Elemetrics Corp.

Lincoln Park, NJ5 decisions1992–19990 recalls

FDA records 5 decisions for Kay Elemetrics Corp. (Lincoln Park, NJ) from 1992 to 1999: 5 510(k) clearances. Most are in product codes EQL (Laryngostroboscope) and KLA (Monitor, Esophageal Motility, Anorectal…). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Kay Elemetrics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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