Cleared Special

PSN HEMODIALYZER, MODELS PSN 170, PSN 210 (K001422) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001422 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2000
Decision
28d
Days
Class 2
Risk

K001422 is an FDA 510(k) clearance for the PSN HEMODIALYZER, MODELS PSN 170, PSN 210. 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 June 2, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K001422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2000
Decision Date June 02, 2000
Days to Decision 28 days
Submission Type Special
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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K001422.
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · Baxter Healthcare Corp · Dec 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · Baxter Healthcare Corp · Nov 2002
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp · Nov 1999
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · Baxter Healthcare Corp · Jul 1998
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
K980656 · Baxter Healthcare Corp · May 1998