Nipro Medical Corporation
Doral, FL, US
NIPRO MEDICAL CORPORATION appears in FDA device records in Doral, FL. FDA records list 62 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Nipro Medical Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Nipro Corprecall
510(k) clearance history
Showing 50 of 62FDA records hold 62 510(k) clearances for Nipro Medical Corporation between 1997 and 2026. The busiest year on record is 2013, with 8. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 4 |
| 1999 | 1 |
| 2000 | 6 |
| 2001 | 5 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 6 |
| 2013 | 8 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261399 | ELISIO™-HX | QAX | Substantially Equivalent | |
| K253047 | PRESSONE™ | FMI | Substantially Equivalent | |
| K260533 | ELISIO™-H | KDI | Substantially Equivalent | |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | FMI | Substantially Equivalent | |
| K212677 | aboNT SYRINGE | FMF | Substantially Equivalent | |
| K190037 | Cronus HP PTA Balloon Catheter | LIT | Substantially Equivalent | |
| K191359 | Nipro Syringe | FMF | Substantially Equivalent | |
| K182940 | Surdial DX Hemodialysis System | KDI | Substantially Equivalent | |
| K173029 | Nipro Syringe | FMF | Substantially Equivalent | |
| K161681 | Nipro SafeTouch IV Catheter | FOZ | Substantially Equivalent | |
| K160444 | FB-U Hemodialyzer | KDI | Substantially Equivalent | |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | LIT | Substantially Equivalent | |
| K140191 | ELISIO-H HEMODIALYZER | KDI | Substantially Equivalent | |
| K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | FOZ | Substantially Equivalent | |
| K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER | KDI | Substantially Equivalent | |
| K131381 | ELISIO-H HEMODIALYZER | KDI | Substantially Equivalent | |
| K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER | FOZ | Substantially Equivalent | |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | FJI | Substantially Equivalent | |
| K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) | FMF | Substantially Equivalent | |
| K122343 | PUREFLUX-H HEMODIALYZER | KDI | Substantially Equivalent | |
| K122347 | ELISIO-H AND ELISIO-M HEMODIALYZERS | KDI | Substantially Equivalent | |
| K130049 | MONOJECT 12ML SYRINGE | FMF | Substantially Equivalent | |
| K120490 | QUICK SAMPLER HOLDER | JKA | Substantially Equivalent | |
| K113471 | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET | FPA | Substantially Equivalent | |
| K113469 | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE | FMI | Substantially Equivalent | |
| K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET | FPA | Substantially Equivalent | |
| K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET | FJK | Substantially Equivalent | |
| K113429 | SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER | FOZ | Substantially Equivalent | |
| K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | FIE | Substantially Equivalent | |
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | FIE | Substantially Equivalent | |
| K092246 | NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 | LHI | Substantially Equivalent | |
| K091279 | NIPRO DISPOSABLE SYRINGE | FMF | Substantially Equivalent | |
| K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET | FPA | Substantially Equivalent | |
| K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | FIB | Substantially Equivalent | |
| K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 | FJK | Substantially Equivalent | |
| K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE | MPB | Substantially Equivalent | |
| K063368 | NIPRO BIOHOLE NEEDLE | FIE | Substantially Equivalent | |
| K063721 | NIPRO SAFETOUCH II GAMMA | FIE | Substantially Equivalent | |
| K060034 | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE | OCY | Substantially Equivalent | |
| K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP | MEB | Substantially Equivalent | |
| K052474 | NIPRO HYPODERMIC NEEDLE | FMI | Substantially Equivalent | |
| K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L | FMG | Substantially Equivalent | |
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | FOZ | Substantially Equivalent | |
| K030683 | NIPRO DISPOSABLE SYRINGES | FMF | Substantially Equivalent | |
| K022756 | NIPRO BIO-FLEX CATHETER | FOZ | Substantially Equivalent | |
| K013293 | NIPRO HYPODERMIC NEEDLE | FMI | Substantially Equivalent | |
| K013287 | NIPRO SAFELET CATH | FOZ | Substantially Equivalent | |
| K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET | FOZ | Substantially Equivalent | |
| K010264 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | FIB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1056186 | 1000132332 | NIPRO MEDICAL CORPORATION | 3150 NW 107TH AVE, Doral, FL 33172 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- LITCatheter, Angioplasty, Peripheral, Transluminal
- MPBCatheter, Hemodialysis, Non-Implanted
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- QAXHemodialyzer With Expanded Solute Removal Profile
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FIBProtector, Transducer, Dialysis
- MEBPump, Infusion, Elastomeric
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FMGStopcock, I.V. Set
- FMFSyringe, Piston
- LLBSystem, Blood, Extracorporeal And Accessories
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0912-2026 | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | Screw may loosen or fallout of Hemodialysis system | Class II | Open, Classified | |
| Z-1876-2018 | 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 bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge. | There is a possibility of the heparin line is occluded. | Class II | Terminated | |
| Z-0161-2016 | 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. | Class II | Terminated | |
| Z-0624-2016 | 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 for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines. | Blood foaming was found during evaluation of the product. | Class II | Terminated | |
| Z-0599-2016 | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC. | Device has the potential to have torn wings. | Class III | Terminated | |
| Z-1834-2014 | 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. | Class II | Terminated | |
| Z-0138-2013 | AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. | 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. | Class II | Terminated | |
| Z-0137-2013 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. | 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. | Class II | Terminated | |
| Z-0136-2013 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. | 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. | Class II | Terminated | |
| Z-0135-2013 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. | 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. | Class II | Terminated | |
| Z-0134-2013 | 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 vasculature. | 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. | Class II | Terminated | |
| Z-1103-2010 | 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 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). JD+01U3008-5C 1cc 30G x 5/16"; JD+01U3013-5C 1cc 30G x 1/2"; JD+01U3108-5C 1cc 31G x 5/16"; JD+03U3008-5C .3CC 30 g X 5/16"; JD+03U3013-5C .3CC 30 g X 1/2"; JD+03U3108-5C .3cc 31G x 516"; JD+05U3008-5C .5cc 30G x 5/16"; JD+05U3013-5C .5cc 30G x 1/2"; JD+05U3108-5C .5cc 31G x 5/16". | 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, push back into the syringe, or remain in | Terminated | ||
| Z-0408-03 | 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 Fistula Needle Set. | Air or fluid leakage at the hub/needle junction. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain