Cleared Traditional

K070222 - FRESENIUS RENAL ACUTE CARE (RAC 100) FI...

K070222 is the FDA 510(k) clearance for FRESENIUS RENAL ACUTE CARE (RAC 100) FI... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K070222 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
90d
Days
Class 2
Risk

K070222 is an FDA 510(k) clearance for the FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on April 24, 2007 after a review of 90 days - within the typical 510(k) review window.

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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K070222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2007
Decision Date April 24, 2007
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K070222.
OPTIFLUX F250NR, MODEL 0500325E
K082414 · Fresenius Medical Care North America · Oct 2008
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · Gambro, Inc. · Nov 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · Nxstage Medical, Inc. · Aug 2007
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
K062079 · Baxter Healthcare Corporation · Oct 2006
NXSTAGE CARTRIDGE EXPRESS
K061837 · Nxstage Medical, Inc. · Jul 2006
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K053539 · Baxter Healthcare Corporation · May 2006