Cleared Traditional

K992894 - MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576

K992894 is an FDA 510(k) clearance for MERIDIAN HEMODIALYSIS MACHINE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K992894 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
89d
Days
Class 2
Risk

K992894 is an FDA 510(k) clearance for the MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576. 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 November 24, 1999 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K992894

510(k) Number K992894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1999
Decision Date November 24, 1999
Days to Decision 89 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
42d faster than avg
Panel avg: 131d · This submission: 89d
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 304
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K992894.
AF-150 HEMODIALYZER
K992566 · Althin Medical AB · Jan 2000
AF-220 HEMODIALYZER
K992573 · Althin Medical AB · Jan 2000
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · Althin Medical AB an Affiliate of Baxter Intl · Dec 1999
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K993064 · Gambro Renal Care Products · Oct 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