Cascade IOMAX Intraoperative Monitor
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Cadwell Cascade IOMAX EUDAMEDDisposable Goggle Foam FDA UDIIOMAX Adapter FDA UDIIOMAX Extender Pod FDA UDICascade IOMAX Intraoperative Monitor FDA UDI
- Generic Name
- Electromyograph FDA UDINeurophysiologic monitoring system FDA UDI
- Device Name
- Disposable Goggle Foam; 10pk FDA UDI16 Channel Amplifier Input Adapter FDA UDI16 Channel Input Extender FDA UDITCS-9 Output Adapter FDA UDILCSwap IOMAX FDA UDI
- Model / Reference
- 197278-000 EUDAMEDFDA UDI362072-000 EUDAMEDFDA UDI362071-000 EUDAMEDFDA UDI362069-000 EUDAMEDFDA UDI190299-200 EUDAMEDFDA UDINeuro Accessory EUDAMED
- Description
- Disposable Goggle Foam; 10pk FDA UDI16 Channel Amplifier Input Adapter FDA UDI16 Channel Input Extender FDA UDITCS-9 Output Adapter FDA UDILCSwap IOMAX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067102244 EUDAMEDFDA UDI00840067102688 EUDAMEDFDA UDI00840067102671 EUDAMEDFDA UDI00840067102664 EUDAMEDFDA UDI00840067102220 EUDAMEDFDA UDI
- Basic UDI-DI
- 08400671NeuroAccClass13E EUDAMED
- Unit of Use DI
- 20840067102248 EUDAMED
- 510(k) Number
- FDA Product Code
- GWF FDA 510(k)FDA UDIOLT FDA UDIGWJ FDA UDIGZO FDA UDIGWQ FDA UDIIKN FDA UDIETN FDA UDIGWE FDA UDIDQA FDA UDIJXE FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Electromyograph FDA UDINeurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1870 FDA 510(k)
- Regulation Number
- 882.1870 FDA 510(k)FDA UDI882.1400 FDA UDI882.1900 FDA UDI882.1540 FDA UDI890.1375 FDA UDI874.1820 FDA UDI882.1890 FDA UDI870.2700 FDA UDI882.1550 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 2.5 Inch FDA UDI
The Cascade IOMAX Intraoperative Monitor is an electrical stimulator and evoked response device designed for intraoperative neurophysiological monitoring. Classified as an electrical stimulator for evoked response, it is used to monitor neural function during surgery, helping to prevent postoperative neural deficits. The device supports multi-modality monitoring, capturing essential neurophysiological data to enhance clinical outcomes.
Intended for use in operating rooms, the Cascade IOMAX is a reusable medical device that requires proper cleaning and preparation before each use. It complies with FDA 510(k) clearance and MDR regulations, ensuring adherence to safety and performance standards. The device is applicable across neurosurgery, ENT, orthopaedic, vascular, and urology surgeries, and is categorized under regulatory classification GWF.
Frequently asked questions
What types of surgeries can the Cascade IOMAX Intraoperative Monitor be used for during intraoperative neurophysiological monitoring?
The Cascade IOMAX Intraoperative Monitor is designed for use in a variety of surgical specialties, including neurosurgery, ENT (ear, nose, and throat), orthopaedic, vascular, and urology procedures. Its multi-modality monitoring capabilities allow it to capture essential neurophysiological data to help preserve neural function during these surgeries, reducing the risk of postoperative neural deficits.
Is the Cascade IOMAX Intraoperative Monitor a single-use or reusable device, and what preparation is required before each use?
The Cascade IOMAX is a reusable medical device. Before each use, it requires proper cleaning and preparation to ensure safety and performance. This is explicitly noted in the device description, emphasizing the importance of maintenance protocols to maintain its functionality.
What regulatory pathways has the Cascade IOMAX Intraoperative Monitor followed, and what does this mean for its compliance?
The Cascade IOMAX has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). This means the device has been evaluated for safety and performance against established standards, ensuring it meets regulatory requirements for use in clinical settings. The clearance type is traditional, and it falls under the classification of an electrical stimulator for evoked response.
How is the Cascade IOMAX Intraoperative Monitor categorized in terms of regulatory classification, and what does this imply for its intended use?
The Cascade IOMAX is classified under the regulatory product code GWF, which is associated with electrical stimulators for evoked response. This classification is used for filing purposes and does not define its clinical indication. It implies the device is intended for intraoperative neurophysiological monitoring to assess neural function during surgery, supporting specialties like neurosurgery, ENT, orthopaedic, vascular, and urology.
What specialties or clinical fields does the Cascade IOMAX Intraoperative Monitor primarily support, and why is this relevant?
The Cascade IOMAX is primarily supported by the Neurology specialty, as indicated by its advisory committee classification (NE) and medical specialty description. This relevance lies in its role during surgeries where neural integrity is critical—such as neurosurgery, ENT, orthopaedic, vascular, and urology—helping clinicians monitor and preserve neural function in real-time to prevent postoperative complications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cadwell Cascade IOMAX Intraoperative Neuromonitoring Solution, Intraoperative Neuromonitoring IONM IOM NIOM - Cadwell Cascade, PDF Cascade IOMAX System Specifications - cadwell.support, PDF 100880-639 Cascade IOMAX User Guide - cadwell.support
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162199 | Class II | Active |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (11)
- FDA 510(k) K162199 24 fields · synced Oct 8, 2026
- FDA UDI adacae62-65ff-44b1-8b7f-eed011af21e4 36 fields · synced May 25, 2026
- FDA UDI 4d20a68c-2b51-4c69-9c67-bada823be1e4 35 fields · synced May 30, 2026
- FDA UDI ed6047f7-ad23-4866-9c94-c57547b2f6d3 35 fields · synced May 30, 2026
- FDA UDI 7bd3f8b8-6287-4ecc-97fa-272ff6fdb6f3 35 fields · synced May 30, 2026
- FDA UDI 5571c268-16d0-48e2-b1d1-0080baaa3064 35 fields · synced May 30, 2026
- EUDAMED 048a7e70-2a54-4048-907c-0fd08f695ab0 61 fields · synced Jul 8, 2026
- EUDAMED 83f608e6-afd3-4e90-a35e-e7a6ab1335bf 61 fields · synced Jul 9, 2026
- EUDAMED c936b59e-75ef-4ba0-9eeb-79b94d2a1048 61 fields · synced Jul 28, 2026
- EUDAMED f333f3f5-8a54-40cc-b88a-88ff572d2002 61 fields · synced Aug 2, 2026
- EUDAMED bbdd6f2c-5782-4359-a301-49043f10ecbb 61 fields · synced Aug 3, 2026