Cleared Traditional

K080703 - BTI FILTRATION DEIONIZATION EXCHANGE TANK

Also marketed or referenced as:
BTI FILTRATION CARBON EXCHANGE TANK

K080703 is an FDA 510(k) clearance for BTI FILTRATION DEIONIZATION EXCHANGE TANK, manufactured by 4m Ventures, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K080703 · 4m Ventures, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
82d
Days
Class 2
Risk

K080703 is an FDA 510(k) clearance for the BTI FILTRATION DEIONIZATION EXCHANGE TANK. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by 4m Ventures, Inc. (Carrollton, US). The FDA issued a Cleared decision on June 2, 2008 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 4m Ventures, Inc. devices

FDA 510(k) Submission Details - K080703

510(k) Number K080703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date June 02, 2008
Days to Decision 82 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
49d faster than avg
Panel avg: 131d · This submission: 82d
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 K080703.
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · Dipure, LLC · Jul 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K090885 · Nephros, Inc. · Jun 2009
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K082400 · Culligan Soft Water Service Co. · Feb 2009
AQUA PURE DEIONIZER EXCHANGE SERVICE
K072158 · Staubach Barror Water Systems, Inc. · Feb 2008
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K071104 · Flier'S Quality Water Systems, Inc. · Jan 2008
GAMBRO POSICLEAR
K061782 · Gambro Services, Inc. · Jan 2007