510(k) Report

FDA applicant

Medi-Plast Intl., Inc.

Mchenry, IL12 decisions1981–19965 recalls

FDA records 12 decisions for Medi-Plast Intl., Inc. (Mchenry, IL) from 1981 to 1996: 12 510(k) clearances. Most are in product codes KPE (Container, I.V.) and DTL (Adaptor, Stopcock, Manifold, Fitting…). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medi-Plast Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medi-Plast Intl., Inc. since 2007.

Recalls per year

5in 2024

2024: 5
2007high 5 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Medi-Plast”

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