Cleared Traditional

INTERFACE ARTERIAL BLOOD FILTER #40 (K823258) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823258 · Medical, Inc. · Cardiovascular device
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Nov 1982
Decision
22d
Days
Class 2
Risk

K823258 is an FDA 510(k) clearance for the INTERFACE ARTERIAL BLOOD FILTER #40. 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 24, 1982 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

Submission Details

510(k) Number K823258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1982
Decision Date November 24, 1982
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.

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 20
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K823258.
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · Johnson & Johnson Professionals, Inc. · Jan 1987
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · C.R. Bard, Inc. · Dec 1983
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · Terumo Medical Corp. · Dec 1981
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
K812742 · Shiley, Inc. · Nov 1981