Cleared Traditional

K945136 - RENAGUARD DIALYSATE FILTER

K945136 is an FDA 510(k) clearance for RENAGUARD DIALYSATE FILTER, manufactured by Minntech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K945136 · Minntech Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
131d
Days
Class 2
Risk

K945136 is an FDA 510(k) clearance for the RENAGUARD DIALYSATE FILTER. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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.

FDA 510(k) Submission Details - K945136

510(k) Number K945136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date February 28, 1995
Days to Decision 131 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
At panel average
Panel avg: 131d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 - FIP Subsystem, Water Purification

All 114
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K945136.
SERIM HISENSE TEST KIT
K952215 · Serim Research Corp. · Aug 1995
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K920186 · Better Water, Inc. · Jun 1995
MD400 A/B/C/D/E/F/G
K944385 · International Purification Systems, Inc. · Apr 1995
REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION
K931595 · Osmonics, Inc. · Dec 1994
MASTER ALERT
K934848 · Master Hydro Systems, Inc. · Sep 1994
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
K915258 · Aqua-Med Systems, Inc. · Jul 1993
K945136 · RENAGUARD DIALYSATE FILTER
Download PDF FDA Summary Minntech Corp.