Cleared Special

K001422 - PSN HEMODIALYZER, MODELS PSN 170, PSN 210

K001422 is an FDA 510(k) clearance for PSN HEMODIALYZER, manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 28-day FDA review.

K001422 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K001422

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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KDI Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K001422.
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · Toray Industries (America), Inc. · Aug 2000
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
K001250 · Asahi Medical Co., Ltd. · Aug 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
K001156 · Gambro Renal Products · Jul 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · Minntech Corp. · Apr 2000
FRESENIUS 2008K
K994267 · Fresenius Medical Care · Mar 2000
A-22 HEMODIALYZER
K992563 · Althin Medical AB · Jan 2000