510(k) Report

FDA applicant

Akron Catheter, Inc.

Mchenry, IL3 decisions1976–19860 recalls

FDA records 3 decisions for Akron Catheter, Inc. (Mchenry, IL) from 1976 to 1986: 3 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and FGE (Stents, Drains And Dilators For The Biliary…). 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 Akron Catheter, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Akron Catheter, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Akron”

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