FDA applicant

Opticon Medical, Inc.

Gurnee, IL8 decisions1990–20042 recalls

FDA records 8 decisions for Opticon Medical, Inc. (Gurnee, IL) from 1990 to 2004: 8 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and CAZ (Anesthesia Conduction Kit). Its devices cite 8 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Opticon Medical”.

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 Opticon Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opticon Medical, Inc. since 2007.

Recalls per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Opticon Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Opticon”

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

Opticon Corp. 2

Opticon Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Opticon”