Cleared Traditional

K842813 - HEPARIN COATED ARTERIAL BLOOD FILTERS

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

K842813 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K842813

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
Combination Product No
PCCP Authorized No
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.

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 81
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K842813.
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · Cobe Laboratories, Inc. · Feb 1986
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
K853987 · Pall Biomedical Products Co. · Dec 1985
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · Gish Biomedical, Inc. · Jul 1985
PALL EC PLUS FILTER
K834380 · Pall Biomedical Products Co. · Aug 1984
PALL EC PLUS FILTER W/FILTER SLEEVE
K834382 · Pall Biomedical Products Co. · Aug 1984
PEDIATRIC ARTERIAL BLOOD FILTER
K840612 · American Bentley · Apr 1984