Cleared Traditional

K000028 - RENAFLO II HF 2000 HEMOFILTER

K000028 is an FDA 510(k) clearance for RENAFLO II HF 2000 HEMOFILTER, manufactured by Minntech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000028 · Minntech Corp. · Gastroenterology & Urology device
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Apr 2000
Decision
90d
Days
Class 2
Risk

K000028 is an FDA 510(k) clearance for the RENAFLO II HF 2000 HEMOFILTER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 4, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Minntech Corp. devices

FDA 510(k) Submission Details - K000028

510(k) Number K000028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2000
Decision Date April 04, 2000
Days to Decision 90 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: 131d · This submission: 90d
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 270
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K000028.
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
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · Baxter Healthcare Corp · Jun 2000
FRESENIUS 2008K
K994267 · Fresenius Medical Care · Mar 2000
A-22 HEMODIALYZER
K992563 · Althin Medical AB · Jan 2000
AF-180 HEMODIALYZER
K992564 · Althin Medical AB · Jan 2000