Cleared Traditional

K813131 - INTERFACE ARTERIAL BLOOD FILTER

K813131 is an FDA 510(k) clearance for INTERFACE ARTERIAL BLOOD FILTER, manufactured by Medical, 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.

K813131 · Medical, Inc. · Cardiovascular device
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Nov 1981
Decision
22d
Days
Class 2
Risk

K813131 is an FDA 510(k) clearance for the INTERFACE ARTERIAL BLOOD FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 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 Medical, Inc. devices

FDA 510(k) Submission Details - K813131

510(k) Number K813131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1981
Decision Date November 27, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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 81
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K813131.
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 W/40 MICRON SCREE
K812742 · Shiley, Inc. · Nov 1981
SHILEY ARTERIAL FILTER
K811379 · Shiley, Inc. · Jun 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · Delta Medical Industries · Jan 1981