# K230415: Cadwell Guardian

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Aug 17, 2023 after 182 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K941811 (1994). 210 ancestors in all.
No later device cites it as a predicate yet.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162199: Cascade IOMAX Intraoperative Monitor, Cadwell Industries, Inc. (2017) Summary page 5.
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, Inomed Medizintechnik GmbH (2022) Summary page 5.

## Indications for use
The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

Source page: https://510kreport.com/device/K230415
Methodology: https://510kreport.com/methodology