510(k) Report

FDA applicant

Hoffrichter GmbH

Egale, WI3 decisions2003–20060 recalls

FDA records 3 decisions for Hoffrichter GmbH (Egale, WI) from 2003 to 2006: 3 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 5 predicates, 2 of them its own earlier devices. 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, anesthesiology panel, where it files most

How often FDA has decided Hoffrichter GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hoffrichter GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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