Cleared Traditional

K812742 - SHILEY ARTERIAL FILTER W/40 MICRON SCREE

K812742 is an FDA 510(k) clearance for SHILEY ARTERIAL FILTER W/40 MICRON SCREE, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K812742 · Shiley, Inc. · Cardiovascular device
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Nov 1981
Decision
34d
Days
Class 2
Risk

K812742 is an FDA 510(k) clearance for the SHILEY ARTERIAL FILTER W/40 MICRON SCREE. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 34 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K812742

510(k) Number K812742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date November 02, 1981
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K812742.
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982
CARDIOVASCULAR DEVICES
K820045 · Bentley Laboratories, Inc. · Jan 1982
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · Terumo Medical Corp. · Dec 1981
SHILEY ARTERIAL FILTER
K811379 · Shiley, Inc. · Jun 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · Delta Medical Industries · Jan 1981
ARTERIAL BLOOD FILTER BF-37
K802755 · Delta Medical Industries · Jan 1981