Cleared Traditional

K831507 - LOW TRAUMA ARTERIAL FILTER H-640

K831507 is the FDA 510(k) clearance for LOW TRAUMA ARTERIAL FILTER H-640 by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K831507 · C.R. Bard, Inc. · Cardiovascular device
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Dec 1983
Decision
232d
Days
Class 2
Risk

K831507 is an FDA 510(k) clearance for the LOW TRAUMA ARTERIAL FILTER H-640. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 232 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K831507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date December 29, 1983
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 K831507.
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · Gish Biomedical, Inc. · Jul 1985
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · American Bentley · Jan 1985
PEDIATRIC ARTERIAL BLOOD FILTER
K840612 · American Bentley · Apr 1984
INTERSEPT 40 MICRON FILTER W/TUBING
K833476 · Extracorporeal Medical Specialities, Inc. · Dec 1983
INTERSEPT 40 MICRON FILTER
K833477 · Extracorporeal Medical Specialities, Inc. · Dec 1983
PURGES LINES, PL-45 & PL-33
K833048 · American Bentley · Oct 1983