Cleared Traditional

K122952 - NIPRO PUREFLUX-L HEMODIALYZER

K122952 is an FDA 510(k) clearance for NIPRO PUREFLUX-L HEMODIALYZER, manufactured by Nipro Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K122952 · Nipro Medical Corporation · Gastroenterology & Urology device
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Dec 2013
Decision
435d
Days
Class 2
Risk

K122952 is an FDA 510(k) clearance for the NIPRO PUREFLUX-L HEMODIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Suwanee, US). The FDA issued a Cleared decision on December 4, 2013 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Nipro Medical Corporation devices

FDA 510(k) Submission Details - K122952

510(k) Number K122952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date December 04, 2013
Days to Decision 435 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 131d · This submission: 435d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

Product Code FJI Dialyzer, Capillary, Hollow Fiber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FJI Dialyzer, Capillary, Hollow Fiber

All 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K122952.
Hemoflow F3 and F4 Dialyzers
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K043342 · Gambro Renal Products · May 2005
ULTRACONCENTRATOR SYSTEM
K011148 · Interpore Cross Intl. · Jun 2001
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
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IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · Idemsa · Apr 2000
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K992594 · Althin Medical AB · Sep 1999