Cleared Traditional

K201809 - AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201809 · Baxter Healthcare Corportation · Gastroenterology & Urology device
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Mar 2021
Decision
252d
Days
Class 2
Risk

K201809 is an FDA 510(k) clearance for the AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corportation (Round Lake, US). The FDA issued a Cleared decision on March 10, 2021 after a review of 252 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 Baxter Healthcare Corportation devices

Submission Details

510(k) Number K201809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date March 10, 2021
Days to Decision 252 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 130d · This submission: 252d
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 342
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K201809.
ELISIO™-H
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