510(k) Report

FDA applicant

Insight Instruments Mfg., Inc.

Sanford, FL1 decision2000–20000 recalls

FDA records 1 decision for Insight Instruments Mfg., Inc. (Sanford, FL) in 2000: 1 510(k) clearance. All are in product code MPA (Endoilluminator). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insight Instruments Mfg., 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?

  • MPAEndoilluminator1decision

What has FDA decided for it lately?

  • K000252Insight 4000 EndoscopeInsight Instruments Mfg., Inc. · 2000

The one decision as Insight Instruments Mfg., 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 Neuroimaging Systems, LLC 1Insight Instruments, Inc. 1Insight Medbotics, Inc. 1