Cleared Traditional

K093608 - GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

K093608 is an FDA 510(k) clearance for GAMBRO WATER PURIFICATION UNIT, manufactured by Gambro Renal Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K093608 · Gambro Renal Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
251d
Days
Class 2
Risk

K093608 is an FDA 510(k) clearance for the GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Gambro Renal Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on July 29, 2010 after a review of 251 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 Gambro Renal Products, Inc. devices

FDA 510(k) Submission Details - K093608

510(k) Number K093608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2009
Decision Date July 29, 2010
Days to Decision 251 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
120d slower than avg
Panel avg: 131d · This submission: 251d
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 K093608.
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K110285 · Nephros, Inc. · Jul 2011
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K110578 · Mar Cor Purification, Inc. · May 2011
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K102892 · Aqua Sciences, Inc. · Feb 2011
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
K092481 · New Aqua, LLC (Dba Aqua Systems) · Apr 2010
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · Dipure, LLC · Jul 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K090885 · Nephros, Inc. · Jun 2009