FDA applicant

Bruel & Kjaer Industri A/S

Denmark, DK4 decisions1984–19920 recalls

FDA records 4 decisions for Bruel & Kjaer Industri A/S (Denmark, DK) from 1984 to 1992: 4 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and EQL (Laryngostroboscope). 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, radiology panel, where it files most

How often FDA has decided Bruel & Kjaer Industri A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bruel & Kjaer Industri A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bruel & Kjaer Industri A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bruel”

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

Bruel & Kjaer 4 Bruel & Kjaer Instruments, Inc. 4

Bruel & Kjaer Industri A/S

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”