510(k) Report

FDA applicant

Megaplast, Inc.

Mchenry, IL7 decisions1981–19820 recalls

FDA records 7 decisions for Megaplast, Inc. (Mchenry, IL) from 1981 to 1982: 7 510(k) clearances. Most are in product codes KDD (Kit, Surgical Instrument, Disposable) and FJZ (Declotting Tray, Kit (Including Contents)). 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 Megaplast, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Megaplast, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Megaplast, 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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