Cleared Traditional

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM (K013562) - FDA 510(k) Clearance

Also marketed or referenced as:
MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013562 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Dec 2002
Decision
412d
Days
Class 2
Risk

K013562 is an FDA 510(k) clearance for the AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM. 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 December 12, 2002 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K013562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2001
Decision Date December 12, 2002
Days to Decision 412 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
282d slower than avg
Panel avg: 130d · This submission: 412d
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 73
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K013562.
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · Baxter Healthcare Corp · Apr 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · Baxter Healthcare Corp · Apr 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · Baxter Healthcare Corp · Feb 2003
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · Baxter Healthcare Corp · Nov 2002
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · Baxter Healthcare Corp · Jun 2000