Cleared Traditional

K842813 - HEPARIN COATED ARTERIAL BLOOD FILTERS

K842813 is the FDA 510(k) clearance for HEPARIN COATED ARTERIAL BLOOD FILTERS by American Bentley. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K842813 · American Bentley · Cardiovascular device
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Jan 1985
Decision
174d
Days
Class 2
Risk

K842813 is an FDA 510(k) clearance for the HEPARIN COATED ARTERIAL BLOOD FILTERS. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 174 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 American Bentley devices

Submission Details

510(k) Number K842813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1984
Decision Date January 08, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
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 29
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K842813.
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · Johnson & Johnson Professionals, Inc. · Jan 1987
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · Cobe Laboratories, Inc. · Feb 1986
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · Gish Biomedical, Inc. · Jul 1985
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · C.R. Bard, Inc. · Dec 1983
INTERSEPT 40 MICRON FILTER W/TUBING
K833476 · Extracorporeal Medical Specialities, Inc. · Dec 1983
INTERSEPT 40 MICRON FILTER
K833477 · Extracorporeal Medical Specialities, Inc. · Dec 1983