510(k) Report

FDA applicant

The University of Chicago

Mchenry, IL2 decisions1981–19810 recalls

FDA records 2 decisions for The University of Chicago (Mchenry, IL) in 1981: 2 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and GIM (Tubes, Vacuum Sample, With Anticoagulant). 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, general hospital panel, where it files most

How often FDA has decided The University of Chicago’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The University of Chicago since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “The”

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