510(k) Report

FDA applicant

Precision Instruments, Inc.

Grand Blanc, MI4 decisions1980–19870 recalls

FDA records 4 decisions for Precision Instruments, Inc. (Grand Blanc, MI) from 1980 to 1987: 4 510(k) clearances. Most are in product codes HRH (Trephine, Manual, Ophthalmic) and EMF (Knife, Surgical). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Precision Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precision Instruments, 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?

  • HRHTrephine, Manual, Ophthalmic3decisions
  • EMFKnife, Surgical1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K864520Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 19873cite it

What has FDA decided for it lately?

  • K864520Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 1987
  • K860648Barron Twin Blade Trephine for EppikaratophakiaPrecision Instruments, Inc. · 1986
  • K843048Ring Supported Trephine for Cornea TransPrecision Instruments, Inc. · 1984
  • K801585Hessburg-Bfrron TrephinePrecision Instruments, Inc. · 1980

All 4 as Precision Instruments, Inc. →