Cleared Traditional

K990643 - PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE...

K990643 is an FDA 510(k) clearance for PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE..., manufactured by Althin Medical AB an Affiliate of Baxter Intl. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K990643 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
284d
Days
Class 2
Risk

K990643 is an FDA 510(k) clearance for the PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Althin Medical AB an Affiliate of Baxter Intl (Miami Lakes, US). The FDA issued a Cleared decision on December 7, 1999 after a review of 284 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 Althin Medical AB an Affiliate of Baxter Intl devices

FDA 510(k) Submission Details - K990643

510(k) Number K990643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1999
Decision Date December 07, 1999
Days to Decision 284 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
154d slower than avg
Panel avg: 130d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K990643.
FRESENIUS OPTIFLUX 200NR
K002277 · Fresenius Medical Care North America · Aug 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · Baxter Healthcare Corp · Jun 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · Minntech Corp. · Apr 2000
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp · Nov 1999
FRESENIUS BLOOD VOLUME MONITOR
K982926 · Fresenius Medical Care North America · Sep 1999
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
K992275 · Fresenius USA, Inc. · Aug 1999