Cleared Traditional

K081054 - GISH ARTERIAL FILTER WITH HA COATING

K081054 is an FDA 510(k) clearance for GISH ARTERIAL FILTER WITH HA COATING, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K081054 · Gish Biomedical, Inc. · Cardiovascular device
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Jan 2009
Decision
276d
Days
Class 2
Risk

K081054 is an FDA 510(k) clearance for the GISH ARTERIAL FILTER WITH HA COATING. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 276 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K081054

510(k) Number K081054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date January 15, 2009
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K081054.
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · Sorin Group Italia S.R.L. · Dec 2009
TERUMO PALL AL3X ARTERIAL FILTER
K083747 · Terumo Cardiovascular Systems Corp. · Aug 2009
TERUMO PALL AL6X ARTERIAL FILTER
K083834 · Terumo Cardiovascular Systems Corp. · Apr 2009
QUART ARTERIAL FILTER WITH BIOLINE COATING
K082544 · Maquet Cardiopulmonary, AG · Oct 2008
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
K072308 · Sorin Group Italia S.R.L. · Sep 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
K071253 · Medtronic Vascular · Jul 2007