Cleared Traditional

K143583 - Cathivex ¿GV filter units

K143583 is an FDA 510(k) clearance for Cathivex ¿GV filter units, manufactured by Merck Millipore , Ltd.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K143583 · Merck Millipore , Ltd. · General Hospital
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Aug 2015
Decision
236d
Days
Class 2
Risk

K143583 is an FDA 510(k) clearance for the Cathivex ¿GV filter units. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Merck Millipore , Ltd. (Carrigtwohill, IE). The FDA issued a Cleared decision on August 11, 2015 after a review of 236 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Merck Millipore , Ltd. devices

FDA 510(k) Submission Details - K143583

510(k) Number K143583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date August 11, 2015
Days to Decision 236 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 129d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPB Filter, Infusion Line

All 70
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K143583.
Filter Needle for Single Use
K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · Pall Biomedical Products Co. · Jan 1997
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994