Cleared Traditional

K133807 - MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

K133807 is an FDA 510(k) clearance for MARS MONITOR ITC US, manufactured by Gambro Renal Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FLD cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K133807 · Gambro Renal Products, Inc. · Gastroenterology & Urology device
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Mar 2014
Decision
100d
Days
Class 2
Risk

K133807 is an FDA 510(k) clearance for the MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX C.... Classified as Apparatus, Hemoperfusion, Sorbent (product code FLD), Class II - Special Controls.

Submitted by Gambro Renal Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 26, 2014 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5870 - 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 - K133807

510(k) Number K133807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date March 26, 2014
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 131d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLD Device Classification - Class 2, Special Controls

Product Code FLD Apparatus, Hemoperfusion, Sorbent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5870
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 - FLD Apparatus, Hemoperfusion, Sorbent

All 9
Devices cleared under the same product code (FLD) and FDA review panel - the closest regulatory comparables to K133807.
MOLECULAR ADSORBENT RECIRCULATING(MARS)
K113313 · Gambro Renal Products, Inc. · Dec 2012
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
K033262 · Gambro Renal Products · May 2005
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
K992196 · Hemocleanse, Inc. · Sep 1999
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
K984546 · Hemocleanse, Inc. · Aug 1999
AHCS HEMOPERFUSION SYSTEM
K971015 · American Health Care Systems, Inc. · Oct 1997
BIOLOGIC-DT SYSTEM
K953751 · Hemocleanse, Inc. · Feb 1996