Cleared Traditional

K003560 - MAR COR SERVICES BICARB SYSTEM

K003560 is an FDA 510(k) clearance for MAR COR SERVICES BICARB SYSTEM, manufactured by Mar Cor Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K003560 · Mar Cor Services, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
203d
Days
Class 2
Risk

K003560 is an FDA 510(k) clearance for the MAR COR SERVICES BICARB SYSTEM. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Mar Cor Services, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Mar Cor Services, Inc. devices

FDA 510(k) Submission Details - K003560

510(k) Number K003560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date June 08, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIN Device Classification - Class 2, Special Controls

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FIN Tank, Holding, Dialysis

All 12
Devices cleared under the same product code (FIN) and FDA review panel - the closest regulatory comparables to K003560.
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K093641 · Tango3, LLC · Dec 2010
DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM
K060333 · Dialysis Services, Inc. · Sep 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · Ameriwater · Jan 2006
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · Pure Water, Inc. · Apr 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
K993058 · Pure Water, Inc. · Jan 2000
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793 · Better Water, Inc. · Nov 1999