510(k) Report

FDA applicant

Kone Instruments, Inc.

Mchenry, IL12 decisions1982–19870 recalls

FDA records 12 decisions for Kone Instruments, Inc. (Mchenry, IL) from 1982 to 1987: 12 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and JJF (Analyzer, Chemistry, Micro, For Clinical Use). 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, cardiovascular panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kone Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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