Cleared Traditional

K041884 - MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K041884 is an FDA 510(k) clearance for MUELLER WATER CONDITIONING WATER PURIFI..., manufactured by Mueller Water Conditioning, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K041884 · Mueller Water Conditioning, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
231d
Days
Class 2
Risk

K041884 is an FDA 510(k) clearance for the MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Mueller Water Conditioning, Inc. (Houston, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 231 days - an extended review cycle.

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.

View all Mueller Water Conditioning, Inc. devices

FDA 510(k) Submission Details - K041884

510(k) Number K041884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date February 28, 2005
Days to Decision 231 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
100d slower than avg
Panel avg: 131d · This submission: 231d
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 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K041884.
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K042018 · Simply Clean Air & Water, Inc. · Apr 2005
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
K043344 · Dialysis Services, Inc. · Mar 2005
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · Gambro Renal Products · Mar 2005
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · Isopure, Corp. · Oct 2004
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001