510(k) Report

FDA applicant

Biegler Medical Products, Inc.

Carlisle, Ontario, CA1 decision1996–19960 recalls

FDA records 1 decision for Biegler Medical Products, Inc. (Carlisle, Ontario, CA) in 1996: 1 510(k) clearance. All are in product code LGZ (Warmer, Thermal, Infusion Fluid). 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 Biegler Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biegler Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biegler Medical Products, Inc. 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?

  • LGZWarmer, Thermal, Infusion Fluid1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K954769Biegler BW385L Blood & Infusion WarmerBiegler Medical Products, Inc. · 19961cites it

What has FDA decided for it lately?

  • K954769Biegler BW385L Blood & Infusion WarmerBiegler Medical Products, Inc. · 1996

The one decision as Biegler Medical Products, Inc. →

Other applicant names beginning “Biegler”

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

Biegler GmbH 3