Cleared Special

K152953 - CRIT-LINE CLIP (CLIC) BLOOD CHAMBER

K152953 is an FDA 510(k) clearance for CRIT-LINE CLIP (CLIC) BLOOD CHAMBER, manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Special 510(k) pathway after a 29-day FDA review.

K152953 · Fresenius Medical Care North America · Gastroenterology & Urology device
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Nov 2015
Decision
29d
Days
Class 2
Risk

K152953 is an FDA 510(k) clearance for the CRIT-LINE CLIP (CLIC) BLOOD CHAMBER. 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 5, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K152953

510(k) Number K152953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2015
Decision Date November 05, 2015
Days to Decision 29 days
Submission Type Special
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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 137
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K152953.
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
K201207 · Fresenius Medical Care Renal Therapies Group, LLC · Sep 2020
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 IV SYSTEM
K141997 · Fresenius Medical Care · Apr 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