# K162199: Cascade IOMAX Intraoperative Monitor - Pathway: 510(k) (Traditional) - Applicant: Cadwell Industries, Inc. - Decided: Mar 2, 2017 after 209 days - Product code: GWF (Stimulator, Electrical, Evoked Response) - Device class: 2 - Regulation: 21 CFR 882.1870 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 16 generations back to K941811 (1994). 208 ancestors in all. 7 later devices descend from it; 4 cite it directly. 0 of 216 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K142624: Neuromaster G1 MEE200, Nihon Kohden Corporation (2015) Summary page 5. - K051357: DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH, Digitimer, Ltd. (2005) Summary page 6. - K072964: Nicolet Cortical Stimulator, Cardinal Health, Inc. (2008) Summary page 6. - K083124: NIM 3.0, Medtronic Xomed, Inc. (2009) Summary page 6. - K093304: Protektor 32, Natus Medical, Inc. (2010) Summary page 6. - K112718: Nuvasive NVM5 System, Nuvasive, Inc. (2012) Summary page 6. - K120979: Carefusion Nicolet Edx, Carefusion 209, Inc. (2012) Summary page 6. - K141105: Pulse Oximeter, Hunan Accurate Bio-Medical Technology Co., Ltd. (2014) Summary page 6. - K143641: NuVasive NVM5 System, Nu Vasive, Incorporated (2015) Summary page 6. - K152563: Pulse Oximeter (MD300M/MD300K2), Beijing Choice Electronic Technology Co., Ltd. (2016) Summary page 6. ## Most influential descendants - K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own - K233292: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2023), 1 descendant of its own - K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own - K263010: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2026), 0 descendants of its own - K230415: Cadwell Guardian (2023), 0 descendants of its own ## Recalls of this device - Aug 18, 2026 · Class II · Z-0141-2027: Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electric - May 17, 2024 · Class II · Z-2349-2024: Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation. - Apr 23, 2024 · Class II · Z-1882-2024: There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock ## Indications for use The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) 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 well-defined stimuli. The acquired data are necessary to perform somatosensory, auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures. Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, displays, records, and stores the electrical activity of the nervous system in response to the stimulation. EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head. Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions. TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex. Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle. Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores 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) or Twitch Test: IOMAX delivers a train of four pulses and measures, displays, records, and stores the compound muscle action potential amplitude fade for analysis. SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room. IOMAX 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. Source page: https://510kreport.com/device/K162199 Methodology: https://510kreport.com/methodology