Medical Device Manufacturer · US , Lexington , KY

Nipro Medical Corporation

32 submissions · 32 cleared · Since 2005
32
Total
32
Cleared
0
Denied

Nipro Medical Corporation — FDA 510(k) Submissions

Nipro Medical Corporation has submitted 32 FDA 510(k) premarket notifications since 2005, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Syringe, Piston, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Catheter, Angioplasty, Peripheral, Transluminal, Needle, Hypodermic, Single Lumen . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
K222852 · FMI Needle, Hypodermic,... · General Hospital
May 2023 246d
aboNT SYRINGE
K212677 · FMF Syringe, Piston · General Hospital
Apr 2022 234d
Cronus HP PTA Balloon Catheter
K190037 · LIT Catheter, Angioplasty,... · Cardiovascular
Oct 2019 289d
Nipro Syringe
K191359 · FMF Syringe, Piston · General Hospital
Oct 2019 141d
Surdial DX Hemodialysis System
K182940 · KDI Dialyzer, High... · Gastroenterology & Urology
Jul 2019 269d
Nipro Syringe
K173029 · FMF Syringe, Piston · General Hospital
Mar 2018 183d
Nipro SafeTouch IV Catheter
K161681 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2017 264d
FB-U Hemodialyzer
K160444 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 2017 357d
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · LIT Catheter, Angioplasty,... · Cardiovascular
Jan 2016 260d
ELISIO-H HEMODIALYZER
K140191 · KDI Dialyzer, High... · Gastroenterology & Urology
Apr 2014 77d
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136 · FOZ Catheter, Intravascular,... · General Hospital
Feb 2014 28d
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2013 176d
ELISIO-H HEMODIALYZER
K131381 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2013 219d
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
K132153 · FOZ Catheter, Intravascular,... · General Hospital
Dec 2013 146d
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Dec 2013 435d
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · FMF Syringe, Piston · General Hospital
Aug 2013 85d
PUREFLUX-H HEMODIALYZER
K122343 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2013 277d
ELISIO-H AND ELISIO-M HEMODIALYZERS
K122347 · KDI Dialyzer, High... · Gastroenterology & Urology
May 2013 271d
MONOJECT 12ML SYRINGE
K130049 · FMF Syringe, Piston · General Hospital
Feb 2013 37d
QUICK SAMPLER HOLDER
K120490 · JKA Tubes, Vials, Systems,... · Chemistry
Dec 2012 314d
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE
K113469 · FMI Needle, Hypodermic,... · General Hospital
Oct 2012 331d
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
K113471 · FPA Set, Administration,... · General Hospital
Oct 2012 331d
NIPRO SAFE TOUCH HUBER INFUSION SET
K113470 · FPA Set, Administration,... · General Hospital
Oct 2012 330d
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Sep 2012 385d
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
K113429 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2012 112d
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