Cleared Traditional

K022747 - HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM

Also marketed or referenced as:
HYDROPURE BACK-UP PEDI SYSTEM

K022747 is an FDA 510(k) clearance for HYDROPURE PORTABLE EXCHANGE DEIONIZATIO..., manufactured by Hydropure Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K022747 · Hydropure Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
176d
Days
Class 2
Risk

K022747 is an FDA 510(k) clearance for the HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Hydropure Systems, Inc. (Orlando, US). The FDA issued a Cleared decision on February 11, 2003 after a review of 176 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 Hydropure Systems, Inc. devices

FDA 510(k) Submission Details - K022747

510(k) Number K022747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2002
Decision Date February 11, 2003
Days to Decision 176 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
45d slower than avg
Panel avg: 131d · This submission: 176d
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 100
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K022747.
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K021560 · Ameriwater · Aug 2003
WATER PURIFICATION SYSTEM
K022448 · Purity Water Company of San Antonio, Inc. · May 2003
PORTABLE RO+ MODEL MROS09
K030059 · Ameriwater · Apr 2003
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K011005 · Pure Water Solutions, Inc. · Nov 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · Mpw Industrial Water Services, Inc. · Aug 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K021352 · Dayton Water Systems · Aug 2002