Cleared Traditional

K840612 - PEDIATRIC ARTERIAL BLOOD FILTER

K840612 is the FDA 510(k) clearance for PEDIATRIC ARTERIAL BLOOD FILTER by American Bentley. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K840612 · American Bentley · Cardiovascular device
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Apr 1984
Decision
64d
Days
Class 2
Risk

K840612 is an FDA 510(k) clearance for the PEDIATRIC ARTERIAL BLOOD FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bentley devices

Submission Details

510(k) Number K840612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1984
Decision Date April 17, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 K840612.
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