Cleared Traditional

ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX (K851003) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851003 · Gish Biomedical, Inc. · Cardiovascular device
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Jul 1985
Decision
139d
Days
Class 2
Risk

K851003 is an FDA 510(k) clearance for the ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 139 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K851003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date July 29, 1985
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K851003.
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · Johnson & Johnson Professionals, Inc. · Jan 1987
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · C.R. Bard, Inc. · Dec 1983
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · Terumo Medical Corp. · Dec 1981