Cleared Traditional

K141997 - CRIT-LINE IV SYSTEM

K141997 is an FDA 510(k) clearance for CRIT-LINE IV SYSTEM, manufactured by Fresenius Medical Care. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K141997 · Fresenius Medical Care · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
252d
Days
Class 2
Risk

K141997 is an FDA 510(k) clearance for the CRIT-LINE IV SYSTEM. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Fresenius Medical Care (Waltham, US). The FDA issued a Cleared decision on April 1, 2015 after a review of 252 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 Fresenius Medical Care devices

FDA 510(k) Submission Details - K141997

510(k) Number K141997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date April 01, 2015
Days to Decision 252 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 130d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 131
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K141997.
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2017
CRIT-LINE III Blood Chamber II
K160749 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2016
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953 · Fresenius Medical Care North America · Nov 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2014
CRIT-LINE CLIP (CLIC)
K121599 · Fresenius Medical Care North America · Nov 2012
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · Nxstage Medical, Inc. · Jul 2008