Cleared Traditional

K943917 - CAPIOX ARTERIAL FILTER

K943917 is an FDA 510(k) clearance for CAPIOX ARTERIAL FILTER, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K943917 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
348d
Days
Class 2
Risk

K943917 is an FDA 510(k) clearance for the CAPIOX ARTERIAL FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K943917

510(k) Number K943917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1994
Decision Date July 25, 1995
Days to Decision 348 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 125d · This submission: 348d
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 K943917.
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular · Feb 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208 · Medtronic Perfusion Systems · Jan 2000
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · Cobe Cardiovascular, Inc. · Sep 1998
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993
GISH ARTERIAL FILTER
K914791 · Gish Biomedical, Inc. · Apr 1993
SHILEY PERFUSION TUBING SETS
K920594 · Shiley, Inc. · Mar 1993