Cleared Traditional

K820343 - ARTERIAL BLOOD FILTER MODEL #AF-1040

K820343 is the FDA 510(k) clearance for ARTERIAL BLOOD FILTER MODEL #AF-1040 by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K820343 · Bentley Laboratories, Inc. · Cardiovascular device
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Jun 1982
Decision
129d
Days
Class 2
Risk

K820343 is an FDA 510(k) clearance for the ARTERIAL BLOOD FILTER MODEL #AF-1040. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1982 after a review of 129 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K820343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1982
Decision Date June 17, 1982
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 58
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K820343.
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
K830132 · American Bentley · Jan 1983
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · Extracorporeal Medical Specialities, Inc. · Nov 1982
ARTERIAL BLOOD FILTER, #AF-1025
K820044 · Bentley Laboratories, Inc. · Jun 1982
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
K820679 · Bentley Laboratories, Inc. · Jun 1982
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982
CARDIOVASCULAR DEVICES
K820045 · Bentley Laboratories, Inc. · Jan 1982