Cleared Traditional

K801147 - PEDIATRIC ARTERIAL BLOOD FILTER #AF-5

K801147 is an FDA 510(k) clearance for PEDIATRIC ARTERIAL BLOOD FILTER #AF-5, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K801147 · Bentley Laboratories, Inc. · Cardiovascular device
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Jun 1980
Decision
22d
Days
Class 2
Risk

K801147 is an FDA 510(k) clearance for the PEDIATRIC ARTERIAL BLOOD FILTER #AF-5. 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 4, 1980 after a review of 22 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 Bentley Laboratories, Inc. devices

FDA 510(k) Submission Details - K801147

510(k) Number K801147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1980
Decision Date June 04, 1980
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 86
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K801147.
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · Delta Medical Industries · Jan 1981
ARTERIAL BLOOD FILTER BF-37
K802755 · Delta Medical Industries · Jan 1981
L-3 PURGE LINE
K802602 · Delta Medical Industries · Nov 1980
ARTERIAL BLOOD FILTER, MODEL AF-10
K792450 · Bentley Laboratories, Inc. · Dec 1979
ULTIPOR BLOOD FILTER EXTRA-CORPOREAL
K791748 · Pall Biomedical Products Co. · Oct 1979
INTERSEPT* BLOOD FILTER W/ TUBING BYPASS
K790435 · Surgikos, Inc. · Mar 1979