Nidek Medical Products Inc

Birmingham, AL, US

NIDEK MEDICAL PRODUCTS, INC. appears in FDA device records in Birmingham, AL. FDA records list 12 510(k) clearances between 1988-11-02 and 2020-05-07, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 9 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 12
PMA records: 0
Recall records: 9
Registered establishments: 1

510(k) clearance history

FDA records hold 12 510(k) clearances for Nidek Medical Products Inc between 1988 and 2020. The busiest year on record is 2004, with 2. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Nidek Medical Products Inc, by decision year
Year	Clearances
1988	1
1995	1
1996	1
1997	1
1998	1
2002	1
2004	2
2008	1
2010	1
2013	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K192693	Nuvo Nano Portable Oxygen Concentrator	CAW	Substantially Equivalent	2020-05-07
K123738	MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD	CAW	Substantially Equivalent	2013-02-28
K093308	MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD	CAW	Substantially Equivalent	2010-01-14
K082566	MARK 5 NUVO LITE OCSI AND STD	CAW	Substantially Equivalent	2008-12-03
K040892	MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905	CAW	Substantially Equivalent	2004-04-29
K032509	MARK 5 NUVO (M5C5)	CAW	Substantially Equivalent	2004-03-18
K020797	PULMO-MIST COMPRESSOR MODEL # 4323	BTI	Substantially Equivalent	2002-05-03
K980551	SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	BZD	Substantially Equivalent	1998-11-17
K962492	SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	BYE	Substantially Equivalent	1997-01-23
K952966	CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	BZD	Substantially Equivalent	1996-05-07
K942593	OXYCHEK OXYGEN ANALYZER	CCL	Substantially Equivalent	1995-05-03
K883591	MARK-5 CONCENTRATOR	CAW	Substantially Equivalent	1988-11-02

Registered establishments

FDA registered establishments for Nidek Medical Products Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1039215	1039215	NIDEK MEDICAL PRODUCTS, INC.	3949 VALLEY EAST INDUSTRIAL DR, Birmingham, AL 35217 US	2026	BTI CAF CAW CAX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1782-2012	NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1781-2012	NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1780-2012	NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1779-2012	NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1778-2012	NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1777-2012	NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1776-2012	NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1775-2012	NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.	Capacitor failure may result in a fire hazard and loss of supplemental oxygen.	Class I	2012-05-01	Terminated
Z-1774-2012	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.	Class I	2012-05-01	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Nidek Medical Products Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain