510(k) Report

FDA applicant

Insight Instruments, Inc.

Sanford, FL1 decision2005–20050 recalls

FDA records 1 decision for Insight Instruments, Inc. (Sanford, FL) in 2005: 1 510(k) clearance. All are in product code HJK (Lens, Contact, Polymethylmethacrylate…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insight 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?

  • HJKLens, Contact, Polymethylmethacrylate, Diagnostic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K051630Super View Disposable Biom Lens SetInsight Instruments, Inc. · 2005

The one decision as Insight Instruments, 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 International, Inc. 2Insight 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 Medbotics, Inc. 1