FDA applicant
Kone Instruments, Inc.
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
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.
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.
See the 510(k) Report