Cleared Traditional

K122347 - ELISIO-H AND ELISIO-M HEMODIALYZERS

K122347 is an FDA 510(k) clearance for ELISIO-H AND ELISIO-M HEMODIALYZERS, manufactured by Nipro Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K122347 · Nipro Medical Corporation · Gastroenterology & Urology device
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May 2013
Decision
271d
Days
Class 2
Risk

K122347 is an FDA 510(k) clearance for the ELISIO-H AND ELISIO-M HEMODIALYZERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Suwanee, US). The FDA issued a Cleared decision on May 1, 2013 after a review of 271 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nipro Medical Corporation devices

FDA 510(k) Submission Details - K122347

510(k) Number K122347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date May 01, 2013
Days to Decision 271 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
140d slower than avg
Panel avg: 131d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K122347.
HEMOCONCENTRATOR
K123288 · Maquet Cardiopulmonary, AG · Jun 2013
PUREFLUX-H HEMODIALYZER
K122343 · Nipro Medical Corporation · May 2013
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K130039 · Gambro Renal Products, Inc. · May 2013
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K122051 · Nxstage Medical, Inc. · Apr 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · Nxstage Medical, Inc. · Mar 2013
ASAHI REXEED-SX/LX SERIES DIALYZER
K121409 · Asahi Kasei Medical Co., Ltd. · Feb 2013