Data / Medical devices / Japan / Nipro Corporation

Nipro Corporation: FDA-registered device maker in Settsu Osaka, Japan, 45 510(k) clearances

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

Nipro Corporation is registered with the FDA (registration 3000247873) in Settsu Osaka, Japan. It lists 27 device types. The FDA files 45 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3000247873
Address: 3-26, Senriokashinmachi, Settsu Osaka, Japan, 566-8510
Owner or operator: NIPRO CORPORATION (8030375)
Roles: Exporter to the US
First device listed: January 18, 2001
Registered through: 2026
Brand names listed: AQUALiner, Aperta NSE PTA Balloon Dilatation Catheter, Dental Needle, ELISIO-09H and 25H., ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M., ELISIO-HX, ELISIO-H, GM-30 Inflation Device and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Exporter to the US	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Exporter to the US	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Exporter to the US	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Exporter to the US	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Exporter to the US	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Exporter to the US	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Exporter to the US	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Exporter to the US	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Exporter to the US	accessdata.fda.gov
Hemodialyzer With Expanded Solute Removal Profile	QAX	2	Exporter to the US	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US	accessdata.fda.gov
Needle, Fistula	FIE	2	Exporter to the US	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Needle, Ophthalmic Suturing	HNM	1	Exporter to the US	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US	accessdata.fda.gov
Protector, Transducer, Dialysis	FIB	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Exporter to the US	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Exporter to the US	accessdata.fda.gov
System, Blood, Extracorporeal And Accessories	LLB	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Exporter to the US	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
July 28, 2026	K261399	ELISIO-HX	QAX	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
March 19, 2026	K260533	ELISIO-H	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
April 22, 2025	K243944	Aperta NSE PTA Balloon Dilatation Catheter	PNO	Substantially Equivalent	Goodman Co., Ltd.	accessdata.fda.gov
June 23, 2021	K210258	NovoFine	FMI	Substantially Equivalent	Novo Nordisk, Inc.	accessdata.fda.gov
December 19, 2020	K202005	NovoFine Plus 32G Tip x 4 mm	FMI	Substantially Equivalent	Novo Nordisk, Inc.	accessdata.fda.gov
October 24, 2019	K190037	Cronus HP PTA Balloon Catheter	LIT	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
July 19, 2019	K182940	Surdial DX Hemodialysis System	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
March 8, 2017	K161681	Nipro SafeTouch IV Catheter	FOZ	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
February 8, 2017	K160444	FB-U Hemodialyzer	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
April 14, 2014	K140191	ELISIO-H HEMODIALYZER	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
December 20, 2013	K131935	ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
December 5, 2013	K132153	SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER	FOZ	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
January 10, 2013	K122687	BLOOD CULTURE HOLDER	JKA	Substantially Equivalent	Greiner Bio-One North America, Inc.	accessdata.fda.gov
October 18, 2012	K113471	NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET	FPA	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
October 18, 2012	K113469	NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE	FMI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
October 17, 2012	K113470	NIPRO SAFE TOUCH HUBER INFUSION SET	FPA	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
September 28, 2012	K112628	NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET	FJK	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
July 25, 2012	K121908	SAFETY INFUSION SET	FMI	Substantially Equivalent	Greiner Bio-One North America, Inc.	accessdata.fda.gov
March 17, 2010	K100520	NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER	FIE	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
March 10, 2010	K093773	AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS	FPA	Substantially Equivalent	Amsino International, Inc.	accessdata.fda.gov
April 24, 2008	K080235	SAFETY INFUSION SET	FMI	Substantially Equivalent	Greiner Bio-One Vacuette North America	accessdata.fda.gov
February 21, 2008	K072988	NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1	FIB	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
October 4, 2007	K072024	NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693	FJK	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
September 7, 2007	K071145	NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE	MPB	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
January 12, 2007	K063721	NIPRO SAFETOUCH II GAMMA	FIE	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
August 14, 2006	K061483	VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES	FMI	Substantially Equivalent	Greiner Bio-One North America, Inc.	accessdata.fda.gov
February 28, 2006	K060034	NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE	OCY	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
November 10, 2005	K052474	NIPRO HYPODERMIC NEEDLE	FMI	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
August 26, 2005	K051574	NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE	FMF	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
November 14, 2003	K032777	MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE	FOZ	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
October 31, 2003	K030683	NIPRO DISPOSABLE SYRINGES	FMF	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
July 12, 2001	K011786	VACUETTE SAFETY BLOOD COLLECTION SET	FMI	Substantially Equivalent	Greiner Vacuette North America, Inc.	accessdata.fda.gov
June 20, 2001	K011297	NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET	FOZ	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
May 14, 2001	K010197	EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET	FPA	Substantially Equivalent	Exelint International, Co.	accessdata.fda.gov
July 7, 2000	K001251	SNIPER, MODEL OR-3872XX SERIES	DQX	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
February 14, 2000	K992699	NIPRO BLOOD COLLECTION NEEDLE	FMI	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
December 4, 1998	K983825	NITRILE LATEX POWDER FREE EXAMINATION GLOVE	LZA	Substantially Equivalent	Top Glove Sdn. Bhd.	accessdata.fda.gov
July 15, 1998	K981619	VACUETTE MULTIPLE SAMPLE LUER ADAPTER	FMI	Substantially Equivalent	Greiner Meditech, Inc.	accessdata.fda.gov
December 17, 1997	K973620	VACUETTE MULTI-SAMPLE NEEDLE	FMI	Substantially Equivalent	Greiner Meditech, Inc.	accessdata.fda.gov
March 28, 1996	K960051	NIPRO SAFELET CATH	FOZ	Substantially Equivalent	Nissho Corp.	accessdata.fda.gov
January 4, 1996	K955053	NIPRO SCALP VEIN SET (DISPOSABL PSV SET)	FOZ	Substantially Equivalent	Nissho Corp.	accessdata.fda.gov
December 7, 1994	K944355	NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES	FMF	Substantially Equivalent	Nissho Corp.	accessdata.fda.gov
December 13, 1990	K903777	WRP FOLEYCATH	EZL	Substantially Equivalent	Wembley Rubber Products (M) Sdn Bhd	accessdata.fda.gov
May 6, 1986	K861152	EXEL VACUUM BLOOD COLLECTING SYSTEM	FMI	Substantially Equivalent	Exel Intl.	accessdata.fda.gov
April 11, 1986	K861150	EXEL DENTAL NEEDLE	DZM	Substantially Equivalent	Exel Intl.	accessdata.fda.gov

Compare with other makers

Updated July 28, 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.