Cleared Traditional

K021615 - BAXTER ACCURA SYSTEM

K021615 is the FDA 510(k) clearance for BAXTER ACCURA SYSTEM by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K021615 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Nov 2002
Decision
186d
Days
Class 2
Risk

K021615 is an FDA 510(k) clearance for the BAXTER ACCURA SYSTEM, MODEL 5M5660. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on November 18, 2002 after a review of 186 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K021615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date November 18, 2002
Days to Decision 186 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
56d slower than avg
Panel avg: 130d · This submission: 186d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K021615.
SYNTRA + DIALYZER, MODEL 200
K023664 · Baxter Healthcare Corp · Feb 2003
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
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NXSTAGE CARTRIDGE EXPRESS
K014152 · Nxstage Medical, Inc. · Dec 2002
NXSTAGE THERAPY SYSTEM
K020858 · Nxstage Medical, Inc. · Apr 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · Nxstage Medical, Inc. · Mar 2002
CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp. · Nov 2001