Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1056186

FEI Number

1000132332

Entity Name

NIPRO MEDICAL CORPORATION

City/State/Country

Doral, FL, US

Establishment Address

3150 NW 107TH AVE, Doral, FL 33172, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K072024

PMA Number

N/A

All Registered Proprietary Names

Nipro Nipro NIPRO BioHole Needle with CAPICK Scab Remover Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set Nipro SafeTouch II Gamma NIPRO Cellentia Dialyzer Nipro SafeTouch II Safety AVF ELISIO-09H and 25H. ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M. Nipro Scalp Vein Set Nipro SafeTouch TULIP Safety AVF Nipro Syringe NIPRO SAFELET CATH Nipro NIPRO Transducer Protector TP-SURE Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle Nipro blood tubing set Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-11-12
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2026-02-02
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2026-02-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2010-04-13
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-11-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-20
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2007-11-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-03-21
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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-11-20
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	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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-03-10
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2001-01-18
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2026-02-02
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2008-03-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-12-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-12-01
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2007-11-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1056186. Last updated year: 2026. Please use registration number 1056186 when referencing this establishment in official correspondence.