510(k) Report

FDA applicant

Surface Mount Technology, Inc.

Cleveland, OH2 decisions1993–19960 recalls

FDA records 2 decisions for Surface Mount Technology, Inc. (Cleveland, OH) from 1993 to 1996: 2 510(k) clearances. Most are in product codes LDQ (Unnamed device) and KTH (Device, Anti-Stammering). 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 Surface Mount Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surface Mount Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LDQUnnamed device1decision
  • KTHDevice, Anti-Stammering1decision

What has FDA decided for it lately?

  • K962961Sustained PhonationSurface Mount Technology, Inc. · 1996
  • K932714Electronic Glove Integrity Monitor (Egim)Surface Mount Technology, Inc. · 1993

All 2 as Surface Mount Technology, Inc. →