Cleared Traditional

K121599 - CRIT-LINE CLIP (CLIC)

K121599 is an FDA 510(k) clearance for CRIT-LINE CLIP (CLIC), manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K121599 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
161d
Days
Class 2
Risk

K121599 is an FDA 510(k) clearance for the CRIT-LINE CLIP (CLIC). Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Waltham, US). The FDA issued a Cleared decision on November 9, 2012 after a review of 161 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 North America devices

FDA 510(k) Submission Details - K121599

510(k) Number K121599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date November 09, 2012
Days to Decision 161 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
30d slower than avg
Panel avg: 131d · This submission: 161d
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 136
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K121599.
CRIT-LINE III Blood Chamber II
K160749 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2016
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K152953 · Fresenius Medical Care North America · Nov 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2014
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · Nxstage Medical, Inc. · Jul 2008
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268 · Fresenius Medical Care North America · Apr 2001
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · Transonic Systems, Inc. · Nov 2000