Cleared Traditional

K042018 - ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

K042018 is an FDA 510(k) clearance for ACUTE PORTABLE EXCHANGE DEIONIZATION (P..., manufactured by Simply Clean Air & Water, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K042018 · Simply Clean Air & Water, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
262d
Days
Class 2
Risk

K042018 is an FDA 510(k) clearance for the ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Simply Clean Air & Water, Inc. (Newington, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 262 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 Simply Clean Air & Water, Inc. devices

FDA 510(k) Submission Details - K042018

510(k) Number K042018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2004
Decision Date April 15, 2005
Days to Decision 262 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
131d slower than avg
Panel avg: 131d · This submission: 262d
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 K042018.
GAMBRO POSICLEAR
K061782 · Gambro Services, Inc. · Jan 2007
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K060942 · Bob J. Johnson & Associates · Jul 2006
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
K051620 · Better Water, Inc. · Nov 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
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K041884 · Mueller Water Conditioning, Inc. · Feb 2005