Cleared Special

K013677 - MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

K013677 is an FDA 510(k) clearance for MODIFICATION TO: MED-RO REVERSE OSMOSIS..., manufactured by Usfilter/Ionpure, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Special 510(k) pathway after a 121-day FDA review.

K013677 · Usfilter/Ionpure, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
121d
Days
Class 2
Risk

K013677 is an FDA 510(k) clearance for the MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Usfilter/Ionpure, Inc. (Lowell, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 121 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Usfilter/Ionpure, Inc. devices

FDA 510(k) Submission Details - K013677

510(k) Number K013677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date March 08, 2002
Days to Decision 121 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 131d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

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 83
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K013677.
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K041884 · Mueller Water Conditioning, Inc. · Feb 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
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000