510(k) Report

FDA applicant

Questech Intl., Inc.

Tampa, FL2 decisions1988–19950 recalls

FDA records 2 decisions for Questech Intl., Inc. (Tampa, FL) from 1988 to 1995: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and LYL (Accessories, Solution, Ultrasonic Cleaners For…). 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 Questech Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Questech Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Questech Intl., 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?

  • FLLContinuous Measurement Thermometer1decision
  • LYLAccessories, Solution, Ultrasonic Cleaners For Lenses1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K884414Clensatron Automatic Contact Lens CleanerQuestech Intl., Inc. · 19884cite it

What has FDA decided for it lately?

  • K943362Pacifier-ThermometerQuestech Intl., Inc. · 1995
  • K884414Clensatron Automatic Contact Lens CleanerQuestech Intl., Inc. · 1988

All 2 as Questech Intl., Inc. →