Data / Medical devices / United States / Nipro Medical Corporation

Nipro Medical Corporation: FDA-registered device maker in Miramar, FL, United States, 28 510(k) clearances

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

Nipro Medical Corporation is registered with the FDA (registration 1056186) in Miramar, FL, United States. It lists 13 device types. The FDA files 28 510(k) clearances under its listings, the newest dated July 28, 2026. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 1056186
FEI number: 1000132332
Address: 3100 Sw 145th Ave Ste 100, Miramar, FL, United States, 33027
Owner or operator: NIPRO CORPORATION (8030375)
Roles: Complaint file establishment
First device listed: January 18, 2001
Registered through: 2027
Brand names listed: ELISIO-09H and 25H., ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M., ELISIO-HX, ELISIO-H, NIPRO BioHole Needle with CAPICK, NIPRO Cellentia Dialyzer, NIPRO SAFELET CATH, NIPRO Transducer Protector TP-SURE and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Complaint file establishment	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Complaint file establishment	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Complaint file establishment	accessdata.fda.gov
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Complaint file establishment	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Complaint file establishment	accessdata.fda.gov
Hemodialyzer With Expanded Solute Removal Profile	QAX	2	Complaint file establishment	accessdata.fda.gov
Needle, Fistula	FIE	2	Complaint file establishment	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Complaint file establishment	accessdata.fda.gov
Protector, Transducer, Dialysis	FIB	2	Complaint file establishment	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Complaint file establishment	accessdata.fda.gov
Syringe, Piston	FMF	2	Complaint file establishment	accessdata.fda.gov
System, Blood, Extracorporeal And Accessories	LLB	2	Complaint file establishment	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
August 4, 2023	K223431	Citric Complete Liquid Citric Acid Concentrate	KPO	Substantially Equivalent	Nipro Renal Solutions USA, Corp.	accessdata.fda.gov
May 25, 2023	K222852	Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle	FMI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
October 9, 2019	K191359	Nipro Syringe	FMF	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 6, 2018	K171750	Citric Complete Dry Citric Acid (45X)	KPO	Substantially Equivalent	Dimesol USA, LLC	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
April 3, 2014	K131202	MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X	KPO	Substantially Equivalent	Dialysis Medical Solutions, LLC	accessdata.fda.gov
December 20, 2013	K131935	ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER	KDI	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
August 28, 2013	K131641	MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)	FMF	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
February 14, 2013	K130049	MONOJECT 12ML SYRINGE	FMF	Substantially Equivalent	Nipro Medical Corporation	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
September 28, 2012	K112628	NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET	FJK	Substantially Equivalent	Nipro Medical Corporation	accessdata.fda.gov
March 17, 2010	K100520	NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER	FIE	Substantially Equivalent	Nipro Medical Corporation	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
November 14, 2003	K032777	MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE	FOZ	Substantially Equivalent	Nipro Medical Corp.	accessdata.fda.gov
January 18, 2002	K012547	HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION	KPO	Substantially Equivalent	Di-Chem, 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
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
July 27, 1990	K901471	GC-1000 THROUGH GC-3005 ACID CONCENTRATE	KPO	Substantially Equivalent	Granite Chemical Co., 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
October 27, 2025	97914	Class II	Ongoing	Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only	Screw may loosen or fallout of Hemodialysis system	accessdata.fda.gov
December 19, 2017	79834	Class II	Terminated	Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable	There is a possibility of the heparin line is occluded.	accessdata.fda.gov
August 13, 2015	72365	Class II	Terminated	Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.	Some 1 1/4" needles were packaged and labeled in the 1" blister package.	accessdata.fda.gov
March 30, 2015	72701	Class II	Terminated	NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible fo	Blood foaming was found during evaluation of the product.	accessdata.fda.gov
April 1, 2014	72707	Class III	Terminated	NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.	Device has the potential to have torn wings.	accessdata.fda.gov
May 4, 2013	65274	Class II	Terminated	NIPRO Safe Touch Safety Scalp Vein Set	There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.	accessdata.fda.gov
July 27, 2012	63302	Class II	Terminated	AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vascul	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.	accessdata.fda.gov
January 13, 2010	54358	Not yet classified	Terminated	NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. Packaged 10 syring	Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, pus	accessdata.fda.gov
November 8, 2002	25052	Not yet classified	Terminated	The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistu	Air or fluid leakage at the hub/needle junction.	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.