Company · US
Nipro Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
62510(k) clearances (3 in 12 months)
12recalls (1 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMF | Syringe, Piston | 10 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 10 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 9 |
| DQX | Wire, Guide, Catheter | 7 |
| FMI | Needle, Hypodermic, Single Lumen | 7 |
| FIE | Needle, Fistula | 6 |
| FPA | Set, Administration, Intravascular | 5 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 4 |
| FIB | Protector, Transducer, Dialysis | 3 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 |
| LLB | System, Blood, Extracorporeal And Accessories | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2026 | K261399 | ELISIO-HX Nipro Medical Corporation | QAX |
| Mar 24, 2026 | K253047 | PRESSONE Nipro Medical Corporation | FMI |
| Mar 19, 2026 | K260533 | ELISIO-H Nipro Medical Corporation | KDI |
| May 25, 2023 | K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle Nipro Medical Corporation | FMI |
| Apr 15, 2022 | K212677 | aboNT SYRINGE Nipro Medical Corporation | FMF |
| Oct 24, 2019 | K190037 | Cronus HP PTA Balloon Catheter Nipro Medical Corporation | LIT |
| Oct 9, 2019 | K191359 | Nipro Syringe Nipro Medical Corporation | FMF |
| Jul 19, 2019 | K182940 | Surdial DX Hemodialysis System Nipro Medical Corporation | KDI |
| Mar 30, 2018 | K173029 | Nipro Syringe Nipro Medical Corporation | FMF |
| Mar 8, 2017 | K161681 | Nipro SafeTouch IV Catheter Nipro Medical Corporation | FOZ |
| Feb 8, 2017 | K160444 | FB-U Hemodialyzer Nipro Medical Corporation | KDI |
| Jan 14, 2016 | K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter Nipro Medical Corporation | LIT |
| Apr 14, 2014 | K140191 | ELISIO-H HEMODIALYZER Nipro Medical Corporation | KDI |
| Feb 14, 2014 | K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE Nipro Medical Corporation | FOZ |
| Dec 20, 2013 | K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER Nipro Medical Corporation | KDI |
| Dec 19, 2013 | K131381 | ELISIO-H HEMODIALYZER Nipro Medical Corporation | KDI |
| Dec 5, 2013 | K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER Nipro Medical Corporation | FOZ |
| Dec 4, 2013 | K122952 | NIPRO PUREFLUX-L HEMODIALYZER Nipro Medical Corporation | FJI |
| Aug 28, 2013 | K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) Nipro Medical Corporation | FMF |
| May 7, 2013 | K122343 | PUREFLUX-H HEMODIALYZER Nipro Medical Corporation | KDI |
| May 1, 2013 | K122347 | ELISIO-H AND ELISIO-M HEMODIALYZERS Nipro Medical Corporation | KDI |
| Feb 14, 2013 | K130049 | MONOJECT 12ML SYRINGE Nipro Medical Corporation | FMF |
| Dec 27, 2012 | K120490 | QUICK SAMPLER HOLDER Nipro Medical Corporation | JKA |
| Oct 18, 2012 | K113471 | NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET Nipro Medical Corporation | FPA |
| Oct 18, 2012 | K113469 | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE Nipro Medical Corporation | FMI |
| Oct 17, 2012 | K113470 | NIPRO SAFE TOUCH HUBER INFUSION SET Nipro Medical Corporation | FPA |
| Sep 28, 2012 | K112628 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET Nipro Medical Corporation | FJK |
| Mar 12, 2012 | K113429 | SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER Nipro Medical Corporation | FOZ |
| Mar 17, 2010 | K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER Nipro Medical Corporation | FIE |
| Jan 22, 2010 | K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE Nipro Medical Corp. | FIE |
| Nov 12, 2009 | K092246 | NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 Nipro Medical Corporation | LHI |
| Aug 12, 2009 | K091279 | NIPRO DISPOSABLE SYRINGE Nipro Medical Corporation | FMF |
| Oct 21, 2008 | K081210 | NIPRO SAFETOUCH HUBER INFUSTION SET Nipro Medical Corp. | FPA |
| Feb 21, 2008 | K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 Nipro Medical Corporation | FIB |
| Oct 4, 2007 | K072024 | NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 Nipro Medical Corp. | FJK |
| Sep 7, 2007 | K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE Nipro Medical Corporation | MPB |
| Feb 5, 2007 | K063368 | NIPRO BIOHOLE NEEDLE Nipro Medical Corp. | FIE |
| Jan 12, 2007 | K063721 | NIPRO SAFETOUCH II GAMMA Nipro Medical Corp. | FIE |
| Feb 28, 2006 | K060034 | NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE Nipro Medical Corporation | OCY |
| Dec 15, 2005 | K051828 | NIPRO SUREFUSER AMBULATORY INFUSION PUMP Nipro Medical Corporation | MEB |
| Nov 10, 2005 | K052474 | NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. | FMI |
| Aug 26, 2005 | K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE Nipro Medical Corp. | FMF |
| Sep 21, 2004 | K041779 | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L Nipro Medical Corp. | FMG |
| Nov 14, 2003 | K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp. | FOZ |
| Oct 31, 2003 | K030683 | NIPRO DISPOSABLE SYRINGES Nipro Medical Corp. | FMF |
| Oct 18, 2002 | K022756 | NIPRO BIO-FLEX CATHETER Nipro Medical Corp. | FOZ |
| Dec 14, 2001 | K013293 | NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. | FMI |
| Dec 3, 2001 | K013287 | NIPRO SAFELET CATH Nipro Medical Corp. | FOZ |
| Jun 20, 2001 | K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET Nipro Medical Corp. | FOZ |
| Apr 27, 2001 | K010264 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET Nipro Medical Corp. | FIB |
Newest 50 of 62.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2025 | Nipro Medical Corporation Hemodialysis System, Surdial DX
REF: MC+SDX01
Rx Only Open, Classified |
KDI | K182940 |
| Dec 19, 2017 | Nipro Medical Corporation 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 Pri Terminated |
FJK | K072024 |
| Jan 8, 2016 | Nipro Medical Corporation 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 Hemod Terminated |
FJK | K112628 |
| Oct 23, 2015 | Nipro Medical Corporation 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 blo Terminated |
LLB | K071145 |
| Jun 19, 2014 | Nipro Medical Corporation NIPRO Safe Touch Safety Scalp Vein Set Terminated |
FOZ | K011297 |
| Apr 1, 2014 | Nipro Medical Corporation NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC. Terminated |
FOZ | K032777 |
| Oct 25, 2012 | Nipro Medical Corporation 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 dev Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation 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 dev Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation 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 d Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation 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 device Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation 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 devi Terminated |
DQX | K001251 |
| Mar 11, 2010 | Nipro Medical Corporation 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 331 Terminated |
FMF | None listed |