Cleared Traditional

K992894 - MERIDIAN HEMODIALYSIS MACHINE

K992894 is the FDA 510(k) clearance for MERIDIAN HEMODIALYSIS MACHINE by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K992894.
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
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
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
K991520 · Fresenius Medical Care North America · Jul 1999