FDA applicant

Bruel & Kjaer

Naerum 2850, DK4 decisions1991–19930 recalls

FDA records 4 decisions for Bruel & Kjaer (Naerum 2850, DK) from 1991 to 1993: 4 510(k) clearances. Most are in product codes CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase…) and LNH (System, Nuclear Magnetic Resonance Imaging). 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 Bruel & Kjaer’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bruel & Kjaer since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bruel”

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

Bruel & Kjaer Industri A/S 4 Bruel & Kjaer Instruments, Inc. 4

Bruel & Kjaer

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Bruel”