Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000247873

FEI Number

3000247873

Entity Name

NIPRO CORPORATION

City/State/Country

Settsu Osaka, JP

Establishment Address

3-26, Senriokashinmachi, Settsu Osaka 566-8510, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

NIPRO CORPORATION (Owner Number: 8030375)

Owner / Operator Contact Address

3-26, Senriokashinmachi, Settsu, JP-27 566-8510, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K903777

PMA Number

N/A

All Registered Proprietary Names

NIPRO Cellentia Dialyzer Ophthalmic Needle Dental Needle Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set Nipro SafeTouch Safety BCS ELISIO-09H and 25H. Nipro Scalp Vein Set Sniper Hydrophilic Guidewire AQUALiner Nipro Hydrophilic Guidewire NIPRO HYDROPHILIC FOR UR NIPRO Transducer Protector TP-SURE Nipro SafeTouch II Gamma ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M. Safe Touch PSV Winged Infusion Set (with or without filter) Surdial DX Hemodialysis System and Accessories Nipro blood tubing set Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set Nipro SafeTouch TULIP Safety AVF Needle NIPRO BioHole Needle with CAPICK Scab Remover NIPRO SAFELET CATH Nipro Hypodermic Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
DZM	Needle, Dental	Dental	Class 1	872.4730	2008-02-19
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-03-21
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2017-05-31
DZM	Needle, Dental	Dental	Class 1	872.4730	2006-07-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-20
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-11-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-11-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-04-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-11-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-12-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-03
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2007-11-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-05
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2006-03-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-05
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2008-03-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2007-11-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-12-27
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-01-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-09-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-12-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-08
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2007-11-15
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2007-11-15
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2007-11-15
LLB	System, Blood, Extracorporeal And Accessories	Gastroenterology, Urology	Class 2	876.5820	2007-11-15
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-09-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2020-03-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-03-05
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2004-04-16
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2010-04-13
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2001-01-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2005-12-16
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-08
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2017-12-27

Official Correspondent

Nobuhiro Morimoto

US Agent Details

JESSICA OSWALD-MCLEOD Business: NIPRO MEDICAL CORPORATION Email: JessicaO@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

NIPRO CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016250252	SHIBUYA CORPORATION	Kanazawa Ishikawa, JP
9610987	NIPRO CORPORATION ODATE FACTORY	ODATE-SHI Akita, JP
3010377171	PT. Nipro Indonesia Jaya	Karawang Jawa Barat, ID
3004138517	NIPRO (SHANGHAI) CO., LTD.	SHANGHAI, CN
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000247873. Last updated year: 2026. Please use registration number 3000247873 when referencing this establishment in official correspondence.