Data / Medical devices / United States / Nidek Medical Products, Inc.

Nidek Medical Products, Inc.: FDA-registered device maker in Birmingham, AL, United States, 4 510(k) clearances

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

Nidek Medical Products, Inc. is registered with the FDA (registration 1039215) in Birmingham, AL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 7, 2020. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1039215
Address: 3949 Valley East Industrial DR, Birmingham, AL, United States, 35217
Owner or operator: NIDEK MEDICAL PRODUCTS, INC. (1039215)
Roles: Manufacturer, Manufacturer for export
First device listed: November 12, 2007
Registered through: 2026
Brand names listed: Dual Flow (Remote Mounting), GCE Mediline Nuvo 8 (985GC, 985GCUK), GCE Mediline Nuvo Lite (925GC), Mark 5 Nuvo (505, 565, 905, 965), Mark 5 Nuvo 10 OCSI (595, 1005), Mark 5 Nuvo 8 OCSI (585, 985), Mark 5 Nuvo 8 STD (580, 980), Mark 5 Nuvo Lite 3 (935) and more

Devices it lists

Device	Product code	Class	Role	Source
Compressor, Air, Portable	BTI	2	Manufacturer	accessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure Compensated	CAX	1	Manufacturer	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	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
May 7, 2020	K192693	Nuvo Nano Portable Oxygen Concentrator	CAW	Substantially Equivalent	Nidek Medical Products, Inc.	accessdata.fda.gov
February 28, 2013	K123738	MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD	CAW	Substantially Equivalent	Nidek Medical Products, Inc.	accessdata.fda.gov
January 14, 2010	K093308	MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD	CAW	Substantially Equivalent	Nidek Medical Products, Inc.	accessdata.fda.gov
May 3, 2002	K020797	PULMO-MIST COMPRESSOR MODEL # 4323	BTI	Substantially Equivalent	Nidek Medical Products, 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
May 1, 2012	61843	Class I	Terminated	NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	accessdata.fda.gov

Compare with other makers

Updated May 7, 2020. 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.