Cleared Traditional

K840612 - PEDIATRIC ARTERIAL BLOOD FILTER

K840612 is an FDA 510(k) clearance for PEDIATRIC ARTERIAL BLOOD FILTER, 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 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

FDA 510(k) Submission Details - K840612

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
Combination Product No
PCCP Authorized No
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.

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 K840612.
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · American Bentley · Jan 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
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