FDA applicant

Insight Medical Corp.

Bolton, MA3 decisions1994–19980 recalls

FDA records 3 decisions for Insight Medical Corp. (Bolton, MA) from 1994 to 1998: 3 510(k) clearances. Most are in product codes MNG (External Urethral Occluder, Urinary…) and JXE (Device, Nerve Conduction Velocity Measurement). Its devices cite 1 predicate, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Insight Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Insight Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Insight Medical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Insight”

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

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

Insight Medical Corp.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Insight”