510(k) Report

FDA applicant

James J. Schramm

Lake Villa, IL1 decision1996–19960 recalls

FDA records 1 decision for James J. Schramm (Lake Villa, IL) in 1996: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 James J. Schramm’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for James J. Schramm since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen1decision

What has FDA decided for it lately?

  • K950686I.V. Start KitJames J. Schramm · 1996

The one decision as James J. Schramm →

Other applicant names beginning “James”

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

James River Corp. 15James L. Geraci & Associates, Inc. 5James Leckey Design 2James K. Brannon 2James R. Powell 1James Nguyen 1James D Rusin MD, MBA 1James P Boyd 1James Consolidated, Inc. 1James J. Lally 1James Alexander Corp. 1James Korea Co., Ltd. 1