510(k) Report

FDA applicant

Microtech, Inc.

Doylestown, PA2 decisions1986–20020 recalls

FDA records 2 decisions for Microtech, Inc. (Doylestown, PA) from 1986 to 2002: 2 510(k) clearances. Most are in product codes KYB (Lens, Guide, Intraocular) and EFB (Handpiece, Air-Powered, Dental). No recall is linked to its devices.

FDA’s records also spell it “Microtech”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Microtech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Microtech, 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?

  • KYBLens, Guide, Intraocular1decision
  • EFBHandpiece, Air-Powered, Dental1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K022535Microtech Push Button Handpiece, Model MHS-A100Microtech · 20021cites it

What has FDA decided for it lately?

  • K022535Microtech Push Button Handpiece, Model MHS-A100Microtech · 2002
  • K854994Bartell Small Incision Lens GlideMicrotech, Inc. · 1986

The one decision as Microtech, Inc. →The one decision as Microtech →

Other applicant names beginning “Microtech”

FDA records each applicant name separately; these may or may not be the same firm.

Microtech Medical Systems, Inc. 13Microtech Medical, Inc. 1