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Kone Instruments, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
12

What Kone Instruments, Inc. makes

Kone Instruments, Inc. manufactures patient monitoring devices, including stress monitors like the M700 and central station systems such as the CENTRAL STATION 590, designed for real-time clinical observation. Their portfolio also includes electrocardiographs, such as the MODEL E 600 and SIGNA II, for recording resting ECG data, along with disposable ECG electrodes. The company produces selective chemistry analyzers, including the PROGRESS and PROGRESS PLUS series, for laboratory blood analysis, as well as portable patient monitors like the PATIENT MONITOR 575 and MEDIC 4.

Kone Instruments’ devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. The company’s products are registered under U.S. FDA regulations, reflecting compliance with medical device authorization requirements. Their portfolio is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

Newest first, rows 1-12 of 12

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  • M700 Stress Monitor Ref K863466

    Class II
    Active 510(k) 510(k) II

  • Model E 600 Electrocardiograph Ref K860767

    Class II
    Active 510(k) 510(k) II

  • Signa Ii Resting Ecg Electrode Ref K862655

    Class II
    Active 510(k) 510(k) II

  • Microlyte Ref K820541

    Class I
    Active 510(k) 510(k) I

  • 560 Ref K822952

    Class II
    Active 510(k) 510(k) II

  • 'microlyte 4/5' Ref K873345

    Class II
    Active 510(k) 510(k) II

  • Progress Selective Dhemistry Analyz Ref K840200

    Class I
    Active 510(k) 510(k) I

  • Olli 565 Ref K820540

    Class II
    Active 510(k) 510(k) II

  • Patient Monitor 575 Ref K830433

    Class II
    Active 510(k) 510(k) II

  • Medic 4 Ref K853354

    Class II
    Active 510(k) 510(k) II

  • Central Station 590 Ref K830432

    Class II
    Active 510(k) 510(k) II

  • Progress Plus Selective Chemistry Analyzer Ref K870777

    Class I
    Active 510(k) 510(k) I

Rows 1-12 of 12

Frequently asked questions

How many devices does Kone Instruments, Inc. have in the registry?

The registry currently lists 12 devices for Kone Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kone Instruments, Inc.'s devices?

Among its 12 most recently registered devices, Kone Instruments, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Kone Instruments, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Kone Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Kone Instruments, Inc. in the registry?

The most recently registered devices listed for Kone Instruments, Inc. include M700 STRESS MONITOR, MODEL E 600 ELECTROCARDIOGRAPH, SIGNA II RESTING ECG ELECTRODE and MICROLYTE.

Generated automatically from registry data and not verified by a human reviewer.