Nipro Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 32
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0912-2026 | Class II | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only | October 27, 2025 |
| Z-1876-2018 | Class II | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a fil | December 19, 2017 |
| Z-0161-2016 | Class II | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for bloo | August 13, 2015 |
| Z-0624-2016 | Class II | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set | March 30, 2015 |
| Z-0599-2016 | Class III | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. | April 1, 2014 |
| Z-1834-2014 | Class II | NIPRO Safe Touch Safety Scalp Vein Set | May 4, 2013 |
| Z-0134-2013 | Class II | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire i | July 27, 2012 |
| Z-0135-2013 | Class II | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is | July 27, 2012 |
| Z-0137-2013 | Class II | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire | July 27, 2012 |
| Z-0138-2013 | Class II | AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire | July 27, 2012 |
| Z-0136-2013 | Class II | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewir | July 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | May 25, 2023 |
| K212677 | aboNT SYRINGE | April 15, 2022 |
| K190037 | Cronus HP PTA Balloon Catheter | October 24, 2019 |
| K191359 | Nipro Syringe | October 9, 2019 |
| K182940 | Surdial DX Hemodialysis System | July 19, 2019 |
| K173029 | Nipro Syringe | March 30, 2018 |
| K161681 | Nipro SafeTouch IV Catheter | March 8, 2017 |
| K160444 | FB-U Hemodialyzer | February 8, 2017 |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | January 14, 2016 |
| K140191 | ELISIO-H HEMODIALYZER | April 14, 2014 |
| K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | February 14, 2014 |
| K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER | December 20, 2013 |
| K131381 | ELISIO-H HEMODIALYZER | December 19, 2013 |
| K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER | December 5, 2013 |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | December 4, 2013 |
| K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) | August 28, 2013 |
| K122343 | PUREFLUX-H HEMODIALYZER | May 7, 2013 |
| K122347 | ELISIO-H AND ELISIO-M HEMODIALYZERS | May 1, 2013 |
| K130049 | MONOJECT 12ML SYRINGE | February 14, 2013 |
| K120490 | QUICK SAMPLER HOLDER | December 27, 2012 |