Cleared Traditional

PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (K070643) - FDA 510(k) Clearance

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

K070643 · Gambro, Inc. · Gastroenterology & Urology device
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Nov 2007
Decision
239d
Days
Class 2
Risk

K070643 is an FDA 510(k) clearance for the PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 2, 2007 after a review of 239 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 Gambro, Inc. devices

Submission Details

510(k) Number K070643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2007
Decision Date November 02, 2007
Days to Decision 239 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 130d · This submission: 239d
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 78
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K070643.
2008T BlueStar Hemodialysis Machine
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Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · Baxter Healthcare Corp · Jun 2003
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