Data / Medical devices / United States / Cadwell Industries, Inc.

Cadwell Industries, Inc.: FDA-registered device maker in Kennewick, WA, United States, 25 510(k) clearances

Name: Cadwell Industries, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cadwell Industries, Inc. is registered with the FDA (registration 3020018) in Kennewick, WA, United States. It lists 24 device types. The FDA files 25 510(k) clearances under its listings, the newest dated December 18, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3020018
Address: 909 N Kellogg St, Kennewick, WA, United States, 99336
Owner or operator: CADWELL INDUSTRIES, INC. (3020018)
Roles: Manufacturer, Specification developer
First device listed: February 25, 1994
Registered through: 2026
Brand names listed: ApneaTrak, Arc Alterna, Arc Essentia, Arc Synopsis Software, Bar Electrodes, Bluebird Respiratory Effort Belt, Cadwell Detachable Ball Tip Probe Shaft - various lengths, Cadwell Disposable Ball Tip Bent Stimulator Probes - various lenghts and more

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer, Specification developer	accessdata.fda.gov
Device, Galvanic Skin Response Measurement	GZO	2	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Device, Sleep Assessment	LEL	2	Manufacturer	accessdata.fda.gov
Electrode, Cortical	GYC	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer, Specification developer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Interactive Rehabilitation Exercise Devices	LXJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Mechanical, Evoked Response	GZP	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Manufacturer	accessdata.fda.gov
System, Communication, Powered	ILQ	2	Specification developer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Specification developer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 18, 2024	K242424	Bluebird Single-Use Respiratory Effort Belt	MNR	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
August 17, 2023	K230415	Cadwell Guardian	GWF	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
February 20, 2020	K192624	ApneaTrak	OLV	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
September 1, 2018	K181466	Cadwell Zenith System	GWQ	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
July 17, 2018	K180269	Cadwell Apollo System	GWQ	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
March 2, 2017	K162199	Cascade IOMAX Intraoperative Monitor	GWF	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
March 1, 2017	K162383	Cadwell Sierra Summit, Cadwell Sierra Ascent	IKN	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
January 29, 2014	K133355	CADWELL FLEX EEG/PSG	GWQ	Substantially Equivalent	Cadwell Industries, Inc.	accessdata.fda.gov
February 23, 2011	K103128	CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,	ETN	Substantially Equivalent	Cadwell Lab, Inc.	accessdata.fda.gov
March 5, 2007	K061706	CADWELL EASYNET OXIMETER MODULE	DQA	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
November 21, 2006	K061705	CADWELL EASYNET NASAL PRESSURE MODULE	MNR	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
July 1, 2004	K040986	CADWELL LIMB MOVEMENT MODULE	LEL	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
July 1, 2004	K040932	EASYNET BODY POSITION MODULE	LEL	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
June 11, 1998	K971214	KILOWIN	GWE	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
September 12, 1995	K946094	CADWELL EASY AMBULATORY EEG	GWQ	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
December 29, 1994	K933808	EEG CUP ELECTRODE	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
December 19, 1994	K933805	RING ELECTRODE	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
November 10, 1994	K941759	SNORING SENSOR	BZQ	Substantially Equivalent - Subject to Tracking Reg.	Epm Development Systems Corp.	accessdata.fda.gov
October 21, 1994	K933801	ELECTRODE, CUTANEOUS	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
September 7, 1994	K933802	CUTANEOUS ELECTRODE	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
July 26, 1994	K933807	GROUND PLATE ELECTRODE	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
July 8, 1994	K933803	DISPOSABLE TAB ELECTRODE	GXY	Substantially Equivalent	Cadwell Laboratories, Inc.	accessdata.fda.gov
June 1, 1993	K923033	THE TRACKER	LXJ	Substantially Equivalent	Epm Information Systems, Inc.	accessdata.fda.gov
December 7, 1992	K922112	EASYFLOW	BZQ	Substantially Equivalent	Epm Information Systems, Inc.	accessdata.fda.gov
December 28, 1990	K903300	RESP-EZ(TM) RESPIRATORY MONITORING BELT	BZQ	Substantially Equivalent	Epm Information Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 18, 2026	99774	Class II	Ongoing	Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical	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 electrical current to reach the patient.	accessdata.fda.gov
May 17, 2024	94764	Class II	Ongoing	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.	accessdata.fda.gov
April 23, 2024	94504	Class II	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.