FDA applicant

Kontron Instruments, Inc.

Everett, MA58 decisions1981–19970 recalls

FDA records 58 decisions for Kontron Instruments, Inc. (Everett, MA) from 1981 to 1997: 58 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). No recall is linked to its devices.

FDA’s records also spell it “Kontron Instruments , Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Kontron Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kontron Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Kontron”

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

Kontron Medical Systems Sas 4 Kontron Electronics 3 Kontron, Inc. 1 Kontron Elektronik GmbH 1

Kontron Instruments, Inc.

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 “Kontron”