Cadwell Industries Inc
Kennewick, WA, US
CADWELL INDUSTRIES, INC. appears in FDA device records in Kennewick, WA. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Cadwell Industries Inc between 2014 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | GXY | Substantially Equivalent | |
| K250851 | Hypnos (369054-200) | OLZ | Substantially Equivalent | |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | MNR | Substantially Equivalent | |
| K230415 | Cadwell Guardian | GWF | Substantially Equivalent | |
| K201819 | Cadwell Apollo System | GWQ | Substantially Equivalent | |
| K192624 | ApneaTrak | OLV | Substantially Equivalent | |
| K190760 | Cadwell Bolt Software | OLT | Substantially Equivalent | |
| K181466 | Cadwell Zenith System | GWQ | Substantially Equivalent | |
| K180269 | Cadwell Apollo System | GWQ | Substantially Equivalent | |
| K162199 | Cascade IOMAX Intraoperative Monitor | GWF | Substantially Equivalent | |
| K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | IKN | Substantially Equivalent | |
| K161027 | Cadwell AmpliScan | OMA | Substantially Equivalent | |
| K133355 | CADWELL FLEX EEG/PSG | GWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020018 | 3020018 | CADWELL INDUSTRIES, INC. | 909 N Kellogg St, KENNEWICK, WA 99336 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GWLAmplifier, Physiological Signal
- OMAAmplitude-Integrated Electroencephalograph
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- IKDCable, Electrode
- GZODevice, Galvanic Skin Response Measurement
- JXEDevice, Nerve Conduction Velocity Measurement
- LELDevice, Sleep Assessment
- GYCElectrode, Cortical
- GXYElectrode, Cutaneous
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- LXJInteractive Rehabilitation Exercise Devices
- BZQMonitor, Breathing Frequency
- PDQNeurosurgical Nerve Locator
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- OMCReduced- Montage Standard Electroencephalograph
- OLVStandard Polysomnograph With Electroencephalograph
- GWJStimulator, Auditory, Evoked Response
- GWFStimulator, Electrical, Evoked Response
- GZPStimulator, Mechanical, Evoked Response
- ETNStimulator, Nerve
- GWEStimulator, Photic, Evoked Response
- ILQSystem, Communication, Powered
- KGXTape And Bandage, Adhesive
- MNRVentilatory Effort Recorder
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2349-2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation. | Class II | Open, Classified | |
| Z-1882-2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | 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 to the patient. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain