Cleared Traditional

K123288 - HEMOCONCENTRATOR

K123288 is the FDA 510(k) clearance for HEMOCONCENTRATOR by Maquet Cardiopulmonary, AG. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K123288 · Maquet Cardiopulmonary, AG · Gastroenterology & Urology device
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Jun 2013
Decision
247d
Days
Class 2
Risk

K123288 is an FDA 510(k) clearance for the HEMOCONCENTRATOR. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on June 26, 2013 after a review of 247 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K123288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2012
Decision Date June 26, 2013
Days to Decision 247 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
117d slower than avg
Panel avg: 130d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 170
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K123288.
OPTIFLUX ULTRA DIALYZER
K123262 · Fresenius Medical Care North America · Jan 2014
NXSTAGE 1.6M2 DIALYZER
K131050 · Nxstage Medical, Inc. · Dec 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · Fresenius Medical Care Renal Therapies Group, LLC · Oct 2013
NXSTAGE SYSTEM ONE
K122051 · Nxstage Medical, Inc. · Apr 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
K123395 · Nxstage Medical, Inc. · Mar 2013
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
K113023 · Nxstage Medical, Inc. · Dec 2012