Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIPRO PUREFLUX-L HEMODIALYZER

K-Number: K122952 · 2013-12-04

ApplicantNipro Medical Corporation
Decision Date2013-12-04
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIPRO PUREFLUX-L HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K122952. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIPRO PUREFLUX-L HEMODIALYZER?

NIPRO PUREFLUX-L HEMODIALYZER is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Nipro Medical Corporation. The 510(k) number is K122952.

When did NIPRO PUREFLUX-L HEMODIALYZER receive FDA 510(k) clearance?

NIPRO PUREFLUX-L HEMODIALYZER received FDA 510(k) clearance on 2013-12-04, under 510(k) number K122952.

Who is the listed applicant for NIPRO PUREFLUX-L HEMODIALYZER?

The FDA 510(k) record lists Nipro Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIPRO PUREFLUX-L HEMODIALYZER?

The FDA product code for NIPRO PUREFLUX-L HEMODIALYZER is FJI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nipro Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261399ELISIO™-HXK253047PRESSONE™K260533ELISIO™-HK222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleK212677aboNT SYRINGEK190037Cronus HP PTA Balloon Catheter

View all 33 devices →

Related Devices (Code: FJI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North AmericaK991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERSIdemsa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑