Cleared Traditional

K030348 - BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

K030348 is an FDA 510(k) clearance for BIOPURE PORTABLE RO SYSTEM, manufactured by Biolab Equipment Canada , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K030348 · Biolab Equipment Canada , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
260d
Days
Class 2
Risk

K030348 is an FDA 510(k) clearance for the BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Biolab Equipment Canada , Ltd. (Thornhill, Ontario, CA). The FDA issued a Cleared decision on October 21, 2003 after a review of 260 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 Biolab Equipment Canada , Ltd. devices

FDA 510(k) Submission Details - K030348

510(k) Number K030348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date October 21, 2003
Days to Decision 260 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
129d slower than avg
Panel avg: 131d · This submission: 260d
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 101
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K030348.
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
MEGA PURE CART
K031832 · Mega Services · Oct 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · Isopure, Corp. · Oct 2004
AQUABOSS ECORO DIA 50
K032004 · Lauer Ltd., Hong Kong · Oct 2003
MEDRO SPD
K030652 · Usfilter/Ionpure, Inc. · Sep 2003
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K021560 · Ameriwater · Aug 2003