Cleared Traditional

K071104 - ACUTE PORTABLE EXCHANGE DEIONIZATION (P...

K071104 is an FDA 510(k) clearance for ACUTE PORTABLE EXCHANGE DEIONIZATION (P..., manufactured by Flier'S Quality Water Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K071104 · Flier'S Quality Water Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2008
Decision
270d
Days
Class 2
Risk

K071104 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 Flier'S Quality Water Systems, Inc. (Byron Center, US). The FDA issued a Cleared decision on January 14, 2008 after a review of 270 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 Flier'S Quality Water Systems, Inc. devices

FDA 510(k) Submission Details - K071104

510(k) Number K071104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2007
Decision Date January 14, 2008
Days to Decision 270 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
140d slower than avg
Panel avg: 130d · This submission: 270d
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 26
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K071104.
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K171099 · Cantel · Jan 2018
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · Minntech Corp. · Mar 1999
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995