Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020018

FEI Number

3020018

Entity Name

CADWELL INDUSTRIES, INC.

City/State/Country

KENNEWICK, WA, US

Establishment Address

909 N Kellogg St, KENNEWICK, WA 99336, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

CADWELL INDUSTRIES, INC. (Owner Number: 3020018)

Owner / Operator Contact Address

909 NORTH KELLOGG ST., --, Kennewick, WA 99336, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K933802

PMA Number

N/A

All Registered Proprietary Names

EasyNet Limb Movement Module ApneaTrak EasyNet Oximeter Module EasyNet Body Position Module Sleepmate Oximetry Tape Patient Event Switch Cascade IOMAX Cascade Surgical Studio SW CannuTherm; Sleepmate Airflow Sensor EEG Gold Cup Electrode Disposable Tab Electrodes Cadwell Disposable Concentric Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Flush Tip Direct Nerve Stimulator Probes - various lenghts Cadwell Disposable Double Ball Tip Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Bipolar Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Detachable Mono-polar Probe - various lengths Cadwell Disposable Ball Tip Bent Stimulator Probes - various lenghts Cadwell Disposable Ball Tip Direct nerve Stimulator Probes - various lenghts Cadwell Disposable Double Hook Nerve Stimulator Probes - various lengths and angles Cadwell Disposable Triple Hook Nerve Stimulator Probes - various lengths and angles Cadwell Disposable Mono-polar Direct Nerve Stimulator Probes - various lengths Cadwell Detachable Ball Tip Probe Shaft - various lengths Sleepmate Body Position Sensor Probe Extension Cable Disposable Clip-on Leadwire Shielded Interconnect Cable Reference Jumper Mini-Crocodile Clip Lead Wires Extender Pods Disposable Multistage Leadwire Ring Electrodes Bluebird Respiratory Effort Belt RIPmate; Sleepmate Respiratory Effort Sensor Bar Electrodes Arc Essentia Arc Alterna Arc Synopsis Software ApneaTrak Disc Electrodes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2018-07-23
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-07-23
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2018-07-23
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2018-07-23
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2018-07-23
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-07-23
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2007-12-11
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2007-12-11
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2020-02-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2020-02-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2007-12-05
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2007-12-11
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2007-12-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-01-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-09-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-09-13
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2018-09-13
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-09-13
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2016-07-08
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-03-10
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2017-03-10
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2017-03-10
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2017-03-10
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2017-03-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-03-10
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2017-03-10
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2017-03-10
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-03-10
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2017-03-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-05-14
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-11
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-02-13
LXJ	Interactive Rehabilitation Exercise Devices	Physical Medicine	Class 2	890.5360	2021-10-21
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	1994-02-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-11
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-11-18
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-10-25
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-12-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-11
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2014-12-24
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2014-12-24
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2014-12-24
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2014-12-24
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2014-12-24
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2014-12-24
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2024-01-02
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2024-01-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-01-02
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2024-01-02
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2024-01-02
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2024-01-02
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2024-01-02
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2024-01-02
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2024-01-02
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2024-01-02
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2024-01-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-12-11

Official Correspondent

Becky Corral

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CADWELL INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020018. Last updated year: 2026. Please use registration number 3020018 when referencing this establishment in official correspondence.