Data / Medical devices / United States / Compumedics Usa, Inc.

Compumedics Usa, Inc.: FDA-registered device maker in Charlotte, NC, United States, 14 510(k) clearances

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

Compumedics Usa, Inc. is registered with the FDA (registration 1650946) in Charlotte, NC, United States. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated August 28, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1650946
FEI number: 3002716534
Address: 5015 West WT Harris Blvd, Suite E, Charlotte, NC, United States, 28269
Owner or operator: Compumedics USA Inc. (9029712)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: January 24, 2008
Registered through: 2026
Brand names listed: CURRY software, Compumedics Grael System, Compumedics Siesta System, Compumedics Somte PSG System, Compumedics Somte System, Falcon HST, NEUVO, Okti 128 Ch Ambulatory EEG Recorder Only and more

Devices it lists

Device	Product code	Class	Role	Source
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Magnetoencephalograph	OLY	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Media, Electroconductive	GYB	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Source Localization Software For Electroencephalograph Or Magnetoencephalograph	OLX	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Complaint file establishment, Repackager or relabeler	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
August 28, 2025	K252383	Somfit D	MNR	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
February 20, 2025	K242447	Falcon HST	OLV	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
February 9, 2023	K230073	Okti	GWQ	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
February 14, 2020	K191785	Orion LifeSpan MEG	OLY	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
January 15, 2010	K093223	COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG	GWQ	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
September 8, 2008	K081151	COMPUMEDICS NEUVO	GWQ	Substantially Equivalent	Compumedics USA, Ltd.	accessdata.fda.gov
April 14, 2008	K072201	COMPUMEDICS SOMTE PSG RECORDING SYSTEM	MNR	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
December 17, 2003	K033052	CONDUCTIVE EEG ELECTROLYTE	GYB	Substantially Equivalent	Compumedics USA, Ltd.	accessdata.fda.gov
February 6, 2003	K023771	SYNAMPS2	GWQ	Substantially Equivalent	Neuroscan	accessdata.fda.gov
January 21, 2003	K021176	COMPUMEDICS SOMTE SYSTEM	MNR	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
September 19, 2001	K011241	NEUROSOFT'S SOURCE	OLX	Substantially Equivalent	Neurosoft, Inc.	accessdata.fda.gov
February 5, 2001	K001781	CURRY MULTIMODAL NEUROIMAGING SOFTWARE	OLX	Substantially Equivalent	Neurosoft, Inc.	accessdata.fda.gov
December 27, 2000	K003175	COMPUMEDICS SIESTA SYSTEM	OLV	Substantially Equivalent	Compumedics Limited	accessdata.fda.gov
April 18, 2000	K000865	QUIK-CAP	GXY	Substantially Equivalent	Neuroscan	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
February 24, 2005	31197	Not yet classified	Terminated	Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia	Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.	accessdata.fda.gov

Compare with other makers

Updated August 28, 2025. 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.