510(k) Report

FDA applicant

Insight International, Inc.

Acworth, GA2 decisions1986–19910 recalls

FDA records 2 decisions for Insight International, Inc. (Acworth, GA) from 1986 to 1991: 2 510(k) clearances. Most are in product codes HJK (Lens, Contact, Polymethylmethacrylate…) and KDD (Kit, Surgical Instrument, Disposable). 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 Insight International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Insight International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insight International, 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?

  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision
  • KDDKit, Surgical Instrument, Disposable1decision

What has FDA decided for it lately?

  • K910816IN-Sight Surgical Instrument Kits, DisposableInsight International, Inc. · 1991
  • K862094Lens-EzeInsight International, Inc. · 1986

All 2 as Insight International, Inc. →

Other applicant names beginning “Insight”

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

Insight Medical Corp. 3Insight Technologies Instruments, LLC 2Insight Medical Systems, Inc. 2Insight Systems 1Insight Optical Mfg. Co. of Florida, Inc. 1Insight Dental System 1Insight Instruments Mfg., Inc. 1Insight Neuroimaging Systems, LLC 1Insight Instruments, Inc. 1Insight Medbotics, Inc. 1