510(k) Report

FDA applicant

Zee Medical Products Co., Inc.

Mchenry, IL8 decisions1981–19830 recalls

FDA records 8 decisions for Zee Medical Products Co., Inc. (Mchenry, IL) from 1981 to 1983: 8 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

How often FDA has decided Zee Medical Products Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zee Medical Products Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zee Medical Products Co., 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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